Trial Outcomes & Findings for Oral Curcumin for Radiation Dermatitis (NCT NCT01246973)
NCT ID: NCT01246973
Last Updated: 2016-03-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
686 participants
Primary outcome timeframe
6 weeks
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
Curcumin
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
|
Placebo
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 Study
STARTED
|
344
|
342
|
|
Overall Study
COMPLETED
|
283
|
295
|
|
Overall Study
NOT COMPLETED
|
61
|
47
|
Reasons for withdrawal
| Measure |
Curcumin
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
|
Placebo
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 Study
Other
|
38
|
25
|
|
Overall Study
Adverse Event
|
16
|
9
|
|
Overall Study
Withdrawal by Subject
|
7
|
13
|
Baseline Characteristics
Oral Curcumin for Radiation Dermatitis
Baseline characteristics by cohort
| Measure |
Curcumin
n=344 Participants
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
|
Placebo
n=342 Participants
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
n=686 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
344 Participants
n=5 Participants
|
342 Participants
n=7 Participants
|
686 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
501 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
74 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/caucasian
|
307 participants
n=5 Participants
|
293 participants
n=7 Participants
|
600 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black/african american
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other race
|
8 participants
n=5 Participants
|
19 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
344 participants
n=5 Participants
|
342 participants
n=7 Participants
|
686 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe 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.
Outcome measures
| Measure |
Curcumin
n=283 Participants
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
|
Placebo
n=295 Participants
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
|
|---|---|---|
|
Mean Radiation Dermatitis Severity Score
|
2.02 units on a scale
Standard Deviation 0.05
|
1.99 units on a scale
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: 6 weeksMoist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.
Outcome measures
| Measure |
Curcumin
n=283 Participants
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
|
Placebo
n=295 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Moist Desquamation
|
9.541 percentage of participants
|
12.203 percentage of participants
|
Adverse Events
Curcumin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place