A Phase 2/3 interventional study of Curcumin and Placebo in Radiation-induced Dermatitis, sponsored by University of Rochester. Completed. Open to female participants aged 21 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-03-07.
Sponsored by University of Rochester · Phase 2/3, Interventional, and Prevention
The purpose of the study is to determine whether curcumin, an ingredient of some foods, can prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues..
Radiation is a toxic agent and a widely accepted form of treatment for various types of cancer. Approximately half of all women with breast cancer receive radiation therapy. Despite advances in medical technology, radiation therapy still causes severe skin effects. Radiation dermatitis occurs in approximately 90% of patients and ranges in severity from mild redness to more severe skin changes. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it; currently, there is no standard treatment for the prevention of radiation-induced dermatitis. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 686 is above the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Drug: Curcumin
4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Drug: Placebo
4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Also known as: Curcumin C3 Complex
4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Mean Radiation Dermatitis Severity Score
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
Percentage of Subjects With Moist Desquamation
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
| Milestone | Curcumin | Placebo |
|---|---|---|
| Started | 344 | 342 |
| Completed | 283 | 295 |
| Not completed | 61 | 47 |
| Withdrew: Other | 38 | 25 |
| Withdrew: Adverse event | 16 | 9 |
| Withdrew: Withdrawal by subject | 7 | 13 |
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.
| units on a scale | Curcumin | Placebo |
|---|---|---|
| Mean Radiation Dermatitis Severity Score | 2.02 ± 0.05 | 1.99 ± 0.06 |
Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.
| percentage of participants | Curcumin | Placebo |
|---|---|---|
| Percentage of Subjects With Moist Desquamation | 9.541 | 12.203 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Curcumin | — | 0/344 (0%) | 0/344 (0%) |
| Placebo | — | 0/342 (0%) | 0/342 (0%) |
| Age, Continuous(years) | Curcumin | Placebo | Total |
|---|---|---|---|
| Mean | 57.6 ± 0.6 | 57.7 ± 0.5 | 57.6 ± 0.4 |
| Sex: Female, Male(Participants) | Curcumin | Placebo | Total |
|---|---|---|---|
| Female | 344 | 342 | 686 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Curcumin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 7 | 13 |
| Not Hispanic or Latino | 264 | 237 | 501 |
| Unknown or Not Reported | 74 | 98 | 172 |
| Race/Ethnicity, Customized(participants) | Curcumin | Placebo | Total |
|---|---|---|---|
| White/caucasian | 307 | 293 | 600 |
| black/african american | 29 | 30 | 59 |
| other race | 8 | 19 | 27 |
| Region of Enrollment(participants) | Curcumin | Placebo | Total |
|---|---|---|---|
| United States | 344 | 342 | 686 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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