Hypofractionated Radiotherapy in Breast Cancer

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03167359
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arm: 1
• Actual Duration (Months): 101.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.

The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast; Inflammation	Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy	N/A

Detailed Description

As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.

The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

Investigators seek to assess the rate of cutaneous toxicity, the rates of lymphedema determined by arm measurements and Grade 3 brachial plexopathy in patients receiving regional nodal irradiation, as well as local control, quality of life, and fatigue levels.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients
• Actual Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: May 14, 2019
• Actual Study Completion Date: May 14, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Participants with Stage 0-III breast cancer Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.

Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy; Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) [Duration of Study (Up to 18 months)]

   Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.

2. Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline [Duration of Study (Up to 18 months)]

   Number of Participants with 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation.

3. Number of Participants With Grade 3 Brachial Plexopathy [Duration of Study (Up to 18 months)]

   Number of Participants with Grade 3 Brachial Plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales Brachial plexopathy range minimum 0 and maximum 4. The higher the score, the worse the outcome

Secondary Outcome Measures

1. Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC) [Baseline, end of Follow Up (Up to 18 months) (up to 18 months)]

   Ultrasound tissue characterization (UTC) is driven by knowledge of the physics of ultrasound and its interactions with biological tissue, and has traditionally used signal modelling and analysis to characterize and differentiate between healthy and diseased tissue. Change in mean UTC at last assessment (up to 18 months post XRT) was compared to baseline (pre-XRT) measures.

2. Change in Tumor Necrosis Factor (TNF) - Alpha Levels [Baseline, Post Intervention (Up to 18 Months)]

   Blood will be analyzed for TNF-alpha (TNF)-alpha levels and correlated to the development of cutaneous toxicity.

3. Change in Soluble TNF Receptor 2 (sTNFR2) Levels [Baseline, Post Intervention (Up to 18 Months)]

   Blood will be analyzed for soluble TNF receptor 2 (sTNFR2) levels and correlated to the development of cutaneous toxicity.

4. Change in Interleukin (IL)-6 Levels [Baseline, Post Intervention (Up to 18 Months)]

   Blood will be analyzed for interleukin (IL)-6 levels and correlated to the development of cutaneous toxicity.

5. Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels [Baseline, Post Intervention (Up to 18 Months)]

   Blood will be analyzed for IL-1ra levels and correlated to the development of cutaneous toxicity.

6. Change in C - Reactive Protein (CRP) Levels [Baseline, Post Intervention (Up to 18 Months)]

   Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity.

7. Change in Multidimensional Fatigue Inventory (MFI) Score [Baseline, end of Follow Up (Up to 18 months)]

   The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued. The higher the maximum change, the greater increase in fatigue a patient feels.

8. Change in Pittsburgh Sleep Quality Index (PSQI) Score [Baseline, End of Follow Up (Up to 18 months)]

   The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality. The higher the maximum change, the greater increase in sleep disturbances a patient has.

9. Change in Perceived Stress Scale (PSS) Score [Baseline, End of Follow Up (Up to 18 months)]

   The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress. The higher the maximum change, the greater increase in stress the patient feels.

10. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score [Baseline, End of Follow Up (Up to 18 months)]

    The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.

11. Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score [Baseline, End of Follow Up (Up to 18 months)]

    The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.

12. Change in Short Form-36 (SF-36) Health Survey Score [Baseline, End of Follow Up (Up to 18 months)]

    The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.

13. Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score [Baseline, End of Follow Up (Up to 18 months)]

    The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. The GLTEQ specifically inquires about frequency of mild, moderate, and strenuous physical activity done during a typical 7-day period with exercise of more than 15 min or more per day during the previous week. Total score for the Godin leisure-time exercise questionnaire is calculated using this formula.Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The GLTEQ total score can be broken into three categories: less than 14 points = sedentary 14 - 23 points is = moderately active 24 points or more = active The score ranges from 0 to 119.

14. Change in Lent Soma Scale Patient Questionnaire Score [Baseline, End of Follow Up (Up to 18 months)]

    The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.The higher the maximum change, the more increase in breast pain, the patient is perceiving.

15. Change in Breast Pain Level [Baseline, End of Follow Up (Up to 18 months)]

    Participants will be asked to rate their breast pain level on a study specific scale from 0 to 10 where 0 represents no pain, and 10 represents the most extreme pain. The higher the maximum change, the more increase in breast pain, the patient is perceiving.

16. Change in Breast Appearance Satisfaction Score [Baseline, End of Follow Up (Up to 18 months)]

    Participants will be asked to rate the look of their breast on a study specific scale from 0 to 10 where 0 represents not happy, and 10 represents very happy. The higher the maximum change, the more increase in happiness with breast appearance the patient is reporting.

17. Change in Radiated Breast Appearance Score [Baseline, End of Follow Up (Up to 18 months)]

    Participants will be asked to rate how different the look of their radiated breast is compared to their non-radiated breast on a study specific scale from 0 to 10 where 0 represents no difference, and 10 represents completely different.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:

• Prior Chemotherapy for Breast Cancer

• Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body)

• Non-Caucasian Race

• Less than or equal to 50 years of age

• Requiring regional nodal irradiation without evidence of N3 disease

Exclusion Criteria:

• Males will be excluded

• Women who are pregnant or nursing a child may not take part in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Mylin Torres, MD, Emory University

Study Documents (Full-Text)

• Study Protocol - Dec 13, 2016
• Statistical Analysis Plan - Apr 1, 2021

More Information

Publications

None provided.

• Responsible Party: Mylin Torres, MD, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03167359
• Other Study ID Numbers: IRB00047240
• First Posted: May 30, 2017
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mylin Torres, MD, Associate Professor, Emory University: Psychiatry; Radiation Therapy
• Additional relevant MeSH terms: Breast Neoplasms; Inflammation

Study Results

Participant Flow

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Period Title: Overall Study
STARTED	74
COMPLETED	72
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Overall Participants	74
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	55 74.3%
>=65 years	19 25.7%
Sex: Female, Male (Count of Participants)
Female	74 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 4.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	29 39.2%
White	39 52.7%
More than one race	0 0%
Unknown or Not Reported	3 4.1%
Region of Enrollment (participants) [Number]
United States	74 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Description	Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.
Time Frame	Duration of Study (Up to 18 months)

Outcome Measure Data

Analysis Population Description

Data is missing on one participant who completed the study. Another patient developed a contralateral breast cancer during the study and another patient was lost to follow up. These latter two patients did not complete the 1 year post radiation assessment.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	71
Grade 0	60 81.1%
Grade 1	11 14.9%
Grade 2	0 0%
Grade 3	0 0%
Grade 4	0 0%

2. Primary Outcome

Title	Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline
Description	Number of Participants with 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation.
Time Frame	Duration of Study (Up to 18 months)

Outcome Measure Data

Analysis Population Description

30 patients received regional nodal irradiation, and per protocol, this subcohort of patients were assessed for lymphedema and brachial plexopathy. Patients who did not receive regional nodal irradiation did not undergo assessments for brachial plexopathy or lymphedema.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	30
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Number of Participants With Grade 3 Brachial Plexopathy
Description	Number of Participants with Grade 3 Brachial Plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales Brachial plexopathy range minimum 0 and maximum 4. The higher the score, the worse the outcome
Time Frame	Duration of Study (Up to 18 months)

Outcome Measure Data

Analysis Population Description

Per protocol, only patients who received regional nodal irradiation were assessed for brachial plexopathy. 30 enrolled patients received regional nodal irradiation and then were assessed for brachial plexopath.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	30
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC)
Description	Ultrasound tissue characterization (UTC) is driven by knowledge of the physics of ultrasound and its interactions with biological tissue, and has traditionally used signal modelling and analysis to characterize and differentiate between healthy and diseased tissue. Change in mean UTC at last assessment (up to 18 months post XRT) was compared to baseline (pre-XRT) measures.
Time Frame	Baseline, end of Follow Up (Up to 18 months) (up to 18 months)

Outcome Measure Data

Analysis Population Description

One patient did not complete her ultrasound measurements of skin toxicity.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	71
Mean (Standard Deviation) [percentage change in skin thickness]	-0.91 (0.39262)

5. Secondary Outcome

Title	Change in Tumor Necrosis Factor (TNF) - Alpha Levels
Description	Blood will be analyzed for TNF-alpha (TNF)-alpha levels and correlated to the development of cutaneous toxicity.
Time Frame	Baseline, Post Intervention (Up to 18 Months)

Outcome Measure Data

Analysis Population Description

Specimens were not processed due to limited funds

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	0

6. Secondary Outcome

Title	Change in Soluble TNF Receptor 2 (sTNFR2) Levels
Description	Blood will be analyzed for soluble TNF receptor 2 (sTNFR2) levels and correlated to the development of cutaneous toxicity.
Time Frame	Baseline, Post Intervention (Up to 18 Months)

Outcome Measure Data

Analysis Population Description

Specimens were not processed due to limited funds.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	0

7. Secondary Outcome

Title	Change in Interleukin (IL)-6 Levels
Description	Blood will be analyzed for interleukin (IL)-6 levels and correlated to the development of cutaneous toxicity.
Time Frame	Baseline, Post Intervention (Up to 18 Months)

Outcome Measure Data

Analysis Population Description

Specimens were not processed due to limited funds

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	0

8. Secondary Outcome

Title	Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels
Description	Blood will be analyzed for IL-1ra levels and correlated to the development of cutaneous toxicity.
Time Frame	Baseline, Post Intervention (Up to 18 Months)

Outcome Measure Data

Analysis Population Description

Specimens were not processed due to limited funds

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	0

9. Secondary Outcome

Title	Change in C - Reactive Protein (CRP) Levels
Description	Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity.
Time Frame	Baseline, Post Intervention (Up to 18 Months)

Outcome Measure Data

Analysis Population Description

Specimens were not processed due to limited funds

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	0

10. Secondary Outcome

Title	Change in Multidimensional Fatigue Inventory (MFI) Score
Description	The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued. The higher the maximum change, the greater increase in fatigue a patient feels.
Time Frame	Baseline, end of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	72
Mean (Standard Deviation) [score on a scale]	-6.33 (12.96)

11. Secondary Outcome

Title	Change in Pittsburgh Sleep Quality Index (PSQI) Score
Description	The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality. The higher the maximum change, the greater increase in sleep disturbances a patient has.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	72
Mean (Standard Deviation) [score on a scale]	-0.75 (2.77)

12. Secondary Outcome

Title	Change in Perceived Stress Scale (PSS) Score
Description	The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress. The higher the maximum change, the greater increase in stress the patient feels.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	72
Mean (Standard Deviation) [score on a scale]	-2.92 (6.99)

13. Secondary Outcome

Title	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
Description	The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

Patient were asked to complete this instrument only after an amendment was made to the protocol. Therefore, the last 23 patients enrolled completed this survey due to the fact that it was added to the protocol in after the majority of patients had been enrolled on the study.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	23
Mean (Standard Deviation) [score on a scale]	-2.57 (6.82)

14. Secondary Outcome

Title	Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score
Description	The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	72
Mean (Standard Deviation) [score on a scale]	-3.21 (8.81)

15. Secondary Outcome

Title	Change in Short Form-36 (SF-36) Health Survey Score
Description	The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	72
Mean (Standard Deviation) [score on a scale]	11.07 (15.89)

16. Secondary Outcome

Title	Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
Description	The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. The GLTEQ specifically inquires about frequency of mild, moderate, and strenuous physical activity done during a typical 7-day period with exercise of more than 15 min or more per day during the previous week. Total score for the Godin leisure-time exercise questionnaire is calculated using this formula.Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The GLTEQ total score can be broken into three categories: less than 14 points = sedentary 14 - 23 points is = moderately active 24 points or more = active The score ranges from 0 to 119.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

This instrument was added to the protocol in an amendment and therefore the first two patients who were enrolled did not complete this instrument because they participated prior to approval of that amendment.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	70
Mean (Standard Deviation) [score on a scale]	5.21 (21.55)

17. Secondary Outcome

Title	Change in Lent Soma Scale Patient Questionnaire Score
Description	The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.The higher the maximum change, the more increase in breast pain, the patient is perceiving.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

Per protocol, this questionnaire was administered only to patients who received regional nodal irradiation.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	30
Mean (Standard Deviation) [score on a scale]	-1.12 (2.59)

18. Secondary Outcome

Title	Change in Breast Pain Level
Description	Participants will be asked to rate their breast pain level on a study specific scale from 0 to 10 where 0 represents no pain, and 10 represents the most extreme pain. The higher the maximum change, the more increase in breast pain, the patient is perceiving.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

This instrument was added in an amendment to the protocol after a number of patients had already been enrolled. Once approved, patients who were enrolled then completed the instrument at the corresponding timepoints after the amendment was approved.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	57
Mean (Standard Deviation) [score on a scale]	0.26 (2.51)

19. Secondary Outcome

Title	Change in Breast Appearance Satisfaction Score
Description	Participants will be asked to rate the look of their breast on a study specific scale from 0 to 10 where 0 represents not happy, and 10 represents very happy. The higher the maximum change, the more increase in happiness with breast appearance the patient is reporting.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

This questionnaire was added in an amendment after the majority of patients were enrolled on study. Once the amendment was approved by Emory IRB, the questionnaire was administered to the remaining 33 patients.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	33
Mean (Standard Deviation) [score on a scale]	.30 (2.62)

20. Secondary Outcome

Title	Change in Radiated Breast Appearance Score
Description	Participants will be asked to rate how different the look of their radiated breast is compared to their non-radiated breast on a study specific scale from 0 to 10 where 0 represents no difference, and 10 represents completely different.
Time Frame	Baseline, End of Follow Up (Up to 18 months)

Outcome Measure Data

Analysis Population Description

This questionnaire was added as an amendment after the majority of patients had been enrolled and assessed. Once the amendment was Emory IRB approved, the questionnaire was administered to the remaining 31 patients.

Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Measure Participants	31
Mean (Standard Deviation) [score on a scale]	-0.81 (4.02)

Adverse Events

Time Frame	60 months
Arm/Group Title	Participants With Stage 0-III Breast Cancer
Arm/Group Description	Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks. Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
All Cause Mortality
	Participants With Stage 0-III Breast Cancer
	Affected / at Risk (%)	# Events
Total	2/74 (2.7%)
Serious Adverse Events
	Participants With Stage 0-III Breast Cancer
	Affected / at Risk (%)	# Events
Total	3/74 (4.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrance	3/74 (4.1%)	3
Other (Not Including Serious) Adverse Events
	Participants With Stage 0-III Breast Cancer
	Affected / at Risk (%)	# Events
Total	0/74 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.