Oral Curcumin for Radiation Dermatitis
| Tracking Information | |||||
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| First Received Date ICMJE | November 22, 2010 | ||||
| Last Updated Date | June 12, 2012 | ||||
| Start Date ICMJE | February 2011 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01246973 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oral Curcumin for Radiation Dermatitis | ||||
| Official Title ICMJE | Oral Curcumin for Radiation Dermatitis in 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.. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
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| Condition ICMJE | Radiation-induced Dermatitis | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: curcumin
Intervention: Drug: Curcumin |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 508 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01246973 | ||||
| Other Study ID Numbers ICMJE | URCC 10054, URCC 09005, U10CA037420 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Rochester | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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