Oral Curcumin for Radiation Dermatitis
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Purpose
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..
| Condition | Intervention | Phase |
|---|---|---|
|
Radiation-induced Dermatitis |
Drug: Curcumin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients |
- To evaluate the degree to which curcumin can reduce radiation-induced skin reactions in breast cancer patients receiving radiotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The outcome measures will be the severity of radiation dermatitis, using the RDS scale, 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).
- How curcumin can prevent or decrease the incidence of moist desquamation, redness and pain at treatment site [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Secondary outcome measures will be moist desquamation (i.e., RDS 3.5 or higher), redness at treatment site (EI), and pain at treatment site (SF-MPQ-2), taking into consideration the degree to which curcumin can decrease the incidence of moist desquamation, as well as the number of sites of moist desquamation, and to decrease the number of treatment interruptions due to skin reactions.
| Estimated Enrollment: | 508 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: curcumin |
Drug: Curcumin
4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
Other Name: Curcumin C3 Complex
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Gary Morrow, Director, URCC CCOP Research Base, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01246973 History of Changes |
| Obsolete Identifiers: | NCT01238198 |
| Other Study ID Numbers: | URCC 10054, URCC 09005, U10CA037420 |
| Study First Received: | November 22, 2010 |
| Last Updated: | June 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Rochester:
|
Oral Curcumin Radiation Dermatitis Breast Cancer Patients |
Additional relevant MeSH terms:
|
Breast Neoplasms Dermatitis Radiodermatitis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Radiation Injuries Wounds and Injuries Curcumin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013