Curcumin-II: Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer

• Sponsor: Gary Morrow (Other)
• Overall Status: Completed
• CT.gov ID: NCT02556632
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 191
• Locations: 6
• Arms: 3
• Actual Duration (Months): 11.6
• Patients Per Site: 31.8
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

This randomized pilot phase II trial studies and compares prophylactic topical agents in reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss and inflammation during radiation therapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma; Pain; Radiation-Induced Dermatitis; Stage 0 Breast Cancer	Drug: Curcumin-based Gel; Procedure: Dermatologic Complications Management; Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

1. To investigate the effectiveness of Curcumin gel (curcumin-based gel) or HPR Plus™ in reducing radiation dermatitis in breast cancer patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 191 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis
• Actual Study Start Date: Oct 13, 2015
• Actual Primary Completion Date: Sep 30, 2016
• Actual Study Completion Date: Sep 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (curcumin-based gel) Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.	Drug: Curcumin-based Gel; Applied topically; Other Names: Curcumin Gel Psoria-Gold Topical Curcumin ; Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies
Experimental: Arm II (HPR Plus) Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.	Procedure: Dermatologic Complications Management; Apply HPR Plus topically; Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies
Placebo Comparator: Arm III (placebo gel) Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Placebo; Apply placebo gel topically; Other Names: placebo therapy PLCB sham therapy ; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) [Baseline up to 1 week post radiation therapy]

   The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT. The RDS score ranges from 0-4 with higher scores indicating worse outcome.

2. Incidence of Moist Desquamation (Present vs. Absent) [Baseline up to completion of radiation therapy]

   The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher's exact test. Each agent's potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher's exact test.

3. Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration) [Baseline to up to 1 week after completion of radiation therapy]

   The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT. The RDS score ranges from 0-4 with higher scores indicating worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ

• Subjects must be prescribed and scheduled for "conventional fractionated" RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:

• Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy

• Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy

• Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy

• Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy

• Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy

• Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy

• Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy

• Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy

• Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)

• Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT

• Subjects may be currently prescribed hormone treatment or Herceptin therapy

• Subjects must be able to read, speak, and understand English

• Subjects must have the ability to understand and the willingness to sign a written informed consent document

• Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician

Exclusion Criteria:

• Pregnant females are ineligible; all subjects of childbearing potential will be asked if they are pregnant or could be pregnant; the patient must respond "no" to continue with radiation and to participate in this clinical study

• Subjects with bilateral breast cancer are not eligible

• Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)

• Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225)

• Previous radiation to the chest or breast

• Subjects with breast reconstruction prior to RT

• Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)

• Previous diagnosis of collagen vascular disorder or vasculitis

• Presence of unhealed surgical wounds in chest or breast region and/or breast infection

• Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial

• Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Delaware/Christiana Care NCORP	Newark	Delaware	United States	19713
2	Heartland NCORP	Decatur	Illinois	United States	62526
3	Metro-Minnesota NCORP	Minneapolis	Minnesota	United States	55426
4	University of Rochester	Rochester	New York	United States	14642
5	Columbus NCORP	Columbus	Ohio	United States	43215
6	Dayton Oncology Research Program	Dayton	Ohio	United States	45420

Sponsors and Collaborators

• Gary Morrow
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Gary Morrow, University of Rochester NCORP Research Base

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gary Morrow, Director, University of Rochester NCORP Research Base
• ClinicalTrials.gov Identifier: NCT02556632
• Other Study ID Numbers: URCC14079; NCI-2015-00869; URCC14079; URCC-14079; R21CA178648; UG1CA189961
• First Posted: Sep 22, 2015
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms; Breast Carcinoma In Situ; Dermatitis; Radiodermatitis; Curcumin

Study Results

Participant Flow

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies
Period Title: Overall Study
STARTED	64	65	62
COMPLETED	59	59	53
NOT COMPLETED	5	6	9

Baseline Characteristics

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)	Total
Arm/Group Description	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies	Total of all reporting groups
Overall Participants	64	65	62	191
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.0 (11.2)	60.7 (10.5)	59.8 (9.3)	59.8 (10.3)
Sex: Female, Male (Count of Participants)
Female	64 100%	65 100%	62 100%	191 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.1%	0 0%	1 1.6%	3 1.6%
Not Hispanic or Latino	62 96.9%	63 96.9%	61 98.4%	186 97.4%
Unknown or Not Reported	0 0%	2 3.1%	0 0%	2 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 1.5%	1 1.6%	2 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	8 12.5%	9 13.8%	4 6.5%	21 11%
White	55 85.9%	55 84.6%	57 91.9%	167 87.4%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 1.6%	0 0%	0 0%	1 0.5%
Marital Status (Count of Participants)
Married	45 70.3%	37 56.9%	37 59.7%	119 62.3%
Domestic Partner	0 0%	0 0%	1 1.6%	1 0.5%
Divorced	5 7.8%	9 13.8%	16 25.8%	30 15.7%
Separated	1 1.6%	0 0%	1 1.6%	2 1%
Single	8 12.5%	8 12.3%	2 3.2%	18 9.4%
Widowed	5 7.8%	10 15.4%	4 6.5%	19 9.9%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Stage of Disease (Count of Participants)
DCIS	5 7.8%	12 18.5%	11 17.7%	28 14.7%
Stage I	34 53.1%	29 44.6%	22 35.5%	85 44.5%
Stage II	16 25%	18 27.7%	20 32.3%	54 28.3%
Stage III	7 10.9%	5 7.7%	8 12.9%	20 10.5%
Stage IV	2 3.1%	0 0%	0 0%	2 1%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Location of Breast Cancer (Count of Participants)
Left	29 45.3%	27 41.5%	30 48.4%	86 45%
Right	35 54.7%	37 56.9%	31 50%	103 53.9%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Prior Chemotherapy (Count of Participants)
No	30 46.9%	35 53.8%	34 54.8%	99 51.8%
Yes	34 53.1%	29 44.6%	27 43.5%	90 47.1%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Currently on Hormone Therapy (Count of Participants)
No	52 81.3%	48 73.8%	48 77.4%	148 77.5%
Yes	12 18.8%	16 24.6%	13 21%	41 21.5%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Currently on Herceptin Treatment (Count of Participants)
No	56 87.5%	56 86.2%	58 93.5%	170 89%
Yes	8 12.5%	8 12.3%	3 4.8%	19 9.9%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Type of Radiation (Count of Participants)
IMRT	1 1.6%	2 3.1%	2 3.2%	5 2.6%
3D Conformal Whole Breast	63 98.4%	62 95.4%	59 95.2%	184 96.3%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Radiation Boost Planned (Count of Participants)
No	4 6.3%	3 4.6%	2 3.2%	9 4.7%
Yes	60 93.8%	61 93.8%	59 95.2%	180 94.2%
Unknown or Not Reported	0 0%	1 1.5%	1 1.6%	2 1%
Total Radiation Dose Prescribed (Gray units) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Gray units]	58.4 (5.6)	59.5 (4.5)	59.1 (5.2)	59.0 (5.1)
Breast Field Separation (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	22.6 (4.0)	23.8 (4.2)	22.8 (5.5)	23.1 (4.6)

Outcome Measures

1. Primary Outcome

Title	Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)
Description	The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT. The RDS score ranges from 0-4 with higher scores indicating worse outcome.
Time Frame	Baseline up to 1 week post radiation therapy

Outcome Measure Data

Analysis Population Description

Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies
Measure Participants	59	59	53
Mean (Standard Deviation) [units on a scale]	2.68 (0.74)	2.64 (0.74)	2.63 (0.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin-based Gel), Arm II (HPR Plus), Arm III (Placebo Gel)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9306
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Incidence of Moist Desquamation (Present vs. Absent)
Description	The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher's exact test. Each agent's potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher's exact test.
Time Frame	Baseline up to completion of radiation therapy

Outcome Measure Data

Analysis Population Description

Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies
Measure Participants	59	59	53
No Moist Desquamation	44 68.8%	47 72.3%	41 66.1%
Moist Desquamation	15 23.4%	12 18.5%	12 19.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin-based Gel), Arm II (HPR Plus), Arm III (Placebo Gel)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8048
	Comments
	Method	Fisher Exact
	Comments

3. Primary Outcome

Title	Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)
Description	The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT. The RDS score ranges from 0-4 with higher scores indicating worse outcome.
Time Frame	Baseline to up to 1 week after completion of radiation therapy

Outcome Measure Data

Analysis Population Description

Note: Of the 64 who were randomized to Arm 1, 60 completed 1-week post; of the 65 who were randomized to Arm II, 58 completed 1-week post; of the 62 who were randomized to Arm III, 52 completed 1-week post.

Arm/Group Title	Arm I (Curcumin-based Gel)	Arm II (HPR Plus)	Arm III (Placebo Gel)
Arm/Group Description	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies
Measure Participants	60	58	52
Mean (Standard Deviation) [units on a scale]	2.25 (0.99)	2.16 (0.92)	2.15 (0.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Curcumin-based Gel), Arm II (HPR Plus), Arm III (Placebo Gel)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8591
	Comments
	Method	ANOVA
	Comments

Adverse Events

Arm/Group Title	Arm I (Curcumin-based Gel)		Arm II (HPR Plus)		Arm III (Placebo Gel)
Arm/Group Description	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Curcumin-based Gel: Applied topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies		Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Dermatologic Complications Management: Apply HPR Plus topically Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies		Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy. Laboratory Biomarker Analysis: Correlative studies Placebo: Apply placebo gel topically Questionnaire Administration: Ancillary studies
All Cause Mortality
	Arm I (Curcumin-based Gel)		Arm II (HPR Plus)		Arm III (Placebo Gel)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		1/65 (1.5%)		0/62 (0%)
Serious Adverse Events
	Arm I (Curcumin-based Gel)		Arm II (HPR Plus)		Arm III (Placebo Gel)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/64 (4.7%)		2/65 (3.1%)		6/62 (9.7%)
Cardiac disorders
Heart Failure	0/64 (0%)		1/65 (1.5%)		1/62 (1.6%)
Injury, poisoning and procedural complications
Radiation Dermatitis	3/64 (4.7%)		1/65 (1.5%)		4/62 (6.5%)
Nervous system disorders
Headache	0/64 (0%)		0/65 (0%)		1/62 (1.6%)
Respiratory, thoracic and mediastinal disorders
Pleuritic pain	0/64 (0%)		1/65 (1.5%)		0/62 (0%)
Skin and subcutaneous tissue disorders
Dermatitis	1/64 (1.6%)		0/65 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (Curcumin-based Gel)		Arm II (HPR Plus)		Arm III (Placebo Gel)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/64 (12.5%)		3/65 (4.6%)		5/62 (8.1%)
Gastrointestinal disorders
Gastrointestinal disorders - Other: yellow colored bowel movements	0/64 (0%)		0/65 (0%)		1/62 (1.6%)
General disorders
Localized edema - Breast swelling	1/64 (1.6%)		0/65 (0%)		0/62 (0%)
Pain	1/64 (1.6%)		1/65 (1.5%)		0/62 (0%)
Fatigue	0/64 (0%)		1/65 (1.5%)		0/62 (0%)
Pain of skin	0/64 (0%)		0/65 (0%)		1/62 (1.6%)
Immune system disorders
Allergic reaction	1/64 (1.6%)		0/65 (0%)		1/62 (1.6%)
Injury, poisoning and procedural complications
Dermatitis radiation	3/64 (4.7%)		1/65 (1.5%)		0/62 (0%)
Reproductive system and breast disorders
Breast pain	1/64 (1.6%)		1/65 (1.5%)		0/62 (0%)
Nipple pain	1/64 (1.6%)		0/65 (0%)		0/62 (0%)
Skin and subcutaneous tissue disorders
Erythematous papular rash	1/64 (1.6%)		0/65 (0%)		0/62 (0%)
Pain of skin	2/64 (3.1%)		0/65 (0%)		1/62 (1.6%)
Pruritis	3/64 (4.7%)		1/65 (1.5%)		1/62 (1.6%)
Dermatitis radiation	0/64 (0%)		0/65 (0%)		2/62 (3.2%)
Skin and subcutaneous tissue disorders (Other, Specify)	1/64 (1.6%)		0/65 (0%)		0/62 (0%)
Rash maculo-papular	0/64 (0%)		0/65 (0%)		1/62 (1.6%)
Papulpustular rash	0/64 (0%)		0/65 (0%)		1/62 (1.6%)
Vascular disorders
Lymphedema	1/64 (1.6%)		0/65 (0%)		0/62 (0%)
Vascular disorders - Other: hellow colored hidrosis	0/64 (0%)		0/65 (0%)		1/62 (1.6%)

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.