Oral Curcumin for Radiation Dermatitis

• ClinicalTrials.gov Identifier: NCT01246973
• Recruitment Status: Completed
• First Posted: November 24, 2010
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016
• Sponsor: University of Rochester
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Julie Ryan, University of Rochester

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Radiation-induced Dermatitis
• Interventions: Drug: Curcumin; Drug: Placebo
• Enrollment: 686

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Curcumin	Placebo
Arm/Group Description	4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week	4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Period Title: Overall Study
Started	344	342
Completed	283	295
Not Completed	61	47
Reason Not Completed
Other	38	25
Adverse Event	16	9
Withdrawal by Subject	7	13

Baseline Characteristics

Arm/Group Title		Curcumin	Placebo	Total
Arm/Group Description		4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week	4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week	Total of all reporting groups
Overall Number of Baseline Participants		344	342	686
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	344 participants	342 participants	686 participants
		57.6 (0.6)	57.7 (0.5)	57.6 (0.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	344 participants	342 participants	686 participants
	Female	344 100.0%	342 100.0%	686 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	344 participants	342 participants	686 participants
	Hispanic or Latino	6 1.7%	7 2.0%	13 1.9%
	Not Hispanic or Latino	264 76.7%	237 69.3%	501 73.0%
	Unknown or Not Reported	74 21.5%	98 28.7%	172 25.1%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	344 participants	342 participants	686 participants
White/caucasian		307	293	600
black/african american		29	30	59
other race		8	19	27
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	344 participants	342 participants	686 participants
		344	342	686

Outcome Measures

1. Primary Outcome

Title	Mean Radiation Dermatitis Severity Score
Description	The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients). The RDS score ranges from 0-4 with higher scores indicating worse outcome.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Curcumin	Placebo
Arm/Group Description:	4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week	4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Overall Number of Participants Analyzed	283	295
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.02 (0.05)	1.99 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curcumin, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6555
	Comments	[Not Specified]
	Method	F-test
	Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Subjects With Moist Desquamation
Description	Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Curcumin	Placebo
Arm/Group Description:	4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week	4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Overall Number of Participants Analyzed	283	295
Measure Type: Number; Unit of Measure: percentage of participants
	9.541	12.203

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curcumin, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3504
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Curcumin	Placebo
Arm/Group Description	4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week	4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
All-Cause Mortality
	Curcumin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Curcumin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/344 (0.00%)	0/342 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Curcumin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/344 (0.00%)	0/342 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Julie Ryan
• Organization: University of Rochester
• Phone: 585-276-3862
• EMail: julie_ryan@urmc.rochester.edu

• Responsible Party: Julie Ryan, University of Rochester
• ClinicalTrials.gov Identifier: NCT01246973
• Obsolete Identifiers: NCT01238198
• Other Study ID Numbers: URCC 10054; URCC 09005 ( Other Identifier: NCI ); U10CA037420 ( U.S. NIH Grant/Contract ); URCC 10054 ( Other Identifier: University of Rochester )
• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Results First Submitted: January 5, 2016
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016