Oral Curcumin for Radiation Dermatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients

Conditions
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Radiation-induced Dermatitis

Intervention / Treatment
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* Drug: Curcumin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curcumin<br>4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week | Drug: Curcumin<br>* 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week<br>* Other names: Curcumin C3 Complex;|
| Placebo Comparator: Placebo<br>4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week | Drug: Placebo<br>* 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Curcumin, Radiation Dermatitis, Breast Cancer Patients