ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Curcumin for Radiation Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
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

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Curcumin Placebo
Hide 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
Arm/Group Title Curcumin Placebo Total
Hide 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
Hide 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
1.Primary Outcome
Title Mean Radiation Dermatitis Severity Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Curcumin Placebo
Hide 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
Show Statistical Analysis 1 Hide 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]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Curcumin Placebo
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Curcumin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/344 (0.00%)   0/342 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Responsible Party: Julie Ryan, University of Rochester
ClinicalTrials.gov Identifier: NCT01246973     History of Changes
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