Radiation-induced Dermatitis
Conditions
Keywords
Oral Curcumin, Radiation Dermatitis, Breast Cancer Patients
Brief summary
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..
Detailed description
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.
Interventions
DRUGCurcumin
4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
DRUGPlacebo
4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Sponsors
National Cancer Institute (NCI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* a diagnosis of non-inflammatory breast adenocarcinoma (including in situ and bilateral) * scheduled to begin radiotherapy without concurrent chemotherapy; concurrent hormone or Herceptin® (trastuzumab)treatment is okay * can have been treated by lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment * can have had breast reconstruction * scheduled to receive 25-35 radiation treatment sessions (1 session per day) using standard irradiation fractionation (1.8-2.0 Gy per sessions) OR 16-20 radiation treatment sessions (1 session per day) using Canadian irradiation fractionation (2.2-3.0 Gy per session)(100, 101). * able to swallow medication. * three weeks must have elapsed after chemotherapy and surgery before the patient can begin the study * able to understand English
Exclusion criteria
* inflammatory breast cancer * previous radiation therapy to the breast or chest * concurrent chemotherapy treatment * concurrent treatment with anti-coagulants (e.g., coumadin®, warfarin®), or anti-EGFR (human epidermal growth factor receptor) drugs (e.g. Iressa® (gefitinib), Erbitux® (cetuximab, C225); aspirin is allowed * known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) * collagen vascular disease, unhealed surgical sites, or breast infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Radiation Dermatitis Severity Score | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Moist Desquamation | 6 weeks | Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 344 |
| 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 | 342 |
| Total | 686 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 9 |
| Overall Study | Other | 38 | 25 |
| Overall Study | Withdrawal by Subject | 7 | 13 |
Baseline characteristics
| Characteristic | Placebo | Total | Curcumin |
|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 0.5 | 57.6 years STANDARD_DEVIATION 0.4 | 57.6 years STANDARD_DEVIATION 0.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 237 Participants | 501 Participants | 264 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 98 Participants | 172 Participants | 74 Participants |
| Race/Ethnicity, Customized black/african american | 30 participants | 59 participants | 29 participants |
| Race/Ethnicity, Customized other race | 19 participants | 27 participants | 8 participants |
| Race/Ethnicity, Customized White/caucasian | 293 participants | 600 participants | 307 participants |
| Region of Enrollment United States | 342 participants | 686 participants | 344 participants |
| Sex: Female, Male Female | 342 Participants | 686 Participants | 344 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 344 | 0 / 342 |
| serious Total, serious adverse events | 0 / 344 | 0 / 342 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Curcumin | Mean Radiation Dermatitis Severity Score | 2.02 units on a scale | Standard Deviation 0.05 |
| Placebo | Mean Radiation Dermatitis Severity Score | 1.99 units on a scale | Standard Deviation 0.06 |
p-value: 0.6555F-test
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Curcumin | Percentage of Subjects With Moist Desquamation | 9.541 percentage of participants |
| Placebo | Percentage of Subjects With Moist Desquamation | 12.203 percentage of participants |
p-value: 0.3504Chi-squared