Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Completed
• CT.gov ID: NCT00321048
• Collaborator: Breast Cancer Research Foundation (Other)
• Enrollment: 57
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms; Carcinoma, Ductal; Adenocarcinoma	Device: Active Breathing Coordinator	N/A

Detailed Description

50 left sided breast cancer patients will be randomized to receive breast/chest wall irradiation with or without ABC. Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.

After the completion of radiation therapy, patients will be seen on the following schedule:

A follow up examination will take place every 3-6 months for the first two years, then every 4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur annually. A SPECT scan will be obtained at 6 months post therapy.

Patients must be 18 and older and must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

Patients must have also undergone a segmental mastectomy (SM) or Mastectomy.

Patients must not have received prior radiation therapy to the breast at any time for any reason.

Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Left breast/chest wall irradiation with or without ABC (active breathing coordinator)Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABC (Active Breathing coordinator) Patients are randomized to ABC arm will receive radiation with ABC. Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the No ABC arm.	Device: Active Breathing Coordinator; A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
No Intervention: No Active Breathing Coordinator Patients randomized to the No ABC arm will receive radiation without ABC.Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the ABC arm.

Outcome Measures

Primary Outcome Measures

1. Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score [6 months post-radiation]

   Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patient must be 18 and older

• Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

• Patients must have undergone a segmental mastectomy (SM) or Mastectomy

• Patients must not have received prior radiation therapy to the breast at any time for any reason.

• Any patient with active local-regional disease prior to registration is not eligible.

• Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy.

• Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.

• All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

• Patients requiring oxygen

• Sarcoma or Squamous Cell pathology

• Right-sided breast cancers

• Metastatic disease to the breast

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Breast Cancer Research Foundation

Investigators

• Principal Investigator: Richard Zellars, M.D., Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00321048
• Other Study ID Numbers: J0609; NA_00002394
• First Posted: May 3, 2006
• Last Update Posted: Jun 19, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: breast cancer; SPECT; ABC device; Invasive adenocarcinoma of the left breast; Ductal Carcinoma In Situ of the left breast
• Additional relevant MeSH terms: Adenocarcinoma; Breast Neoplasms; Carcinoma, Ductal

Study Results

Participant Flow

Arm/Group Title	Active Breathing Coordination	No Active Breathing Coordination
Arm/Group Description	Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. Patients in this group were treated with Active Breathing Coordinator: A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion	Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion
Period Title: Overall Study
STARTED	28	29
COMPLETED	22	21
NOT COMPLETED	6	8

Baseline Characteristics

Arm/Group Title	Active Breathing Coordination	No Active Breathing Coordination	Total
Arm/Group Description	Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. Patients in this group were treated with Active Breathing Coordinator: A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion	Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion	Total of all reporting groups
Overall Participants	22	21	43
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	52.8	58.7	55.8
Sex: Female, Male (Count of Participants)
Female	22 100%	21 100%	43 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	22 100%	21 100%	43 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score
Description	Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion.
Time Frame	6 months post-radiation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Breathing Coordination	No Active Breathing Coordination
Arm/Group Description	Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. Patients in this group were treated with Active Breathing Coordinator: A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion	Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion
Measure Participants	22	21
Mean Apical Perfusion Pre XRT	1.2 (0.9)	2.0 (1.5)
Mean Apical Perfusion Post XRT	2.1 (1.5)	2.5 (1.6)

Adverse Events

Time Frame	up to 4 years
Arm/Group Title	Active Breathing Coordination		No Active Breathing Coordination
Arm/Group Description	Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. Patients in this group were treated with Active Breathing Coordinator: A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion		Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. (Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion
All Cause Mortality
	Active Breathing Coordination		No Active Breathing Coordination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	02/22 (9.1%)		1/21 (4.8%)
Serious Adverse Events
	Active Breathing Coordination		No Active Breathing Coordination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Active Breathing Coordination		No Active Breathing Coordination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/21 (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.