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Trial record 28 of 153 for:    Enzyme | curcumin

Oral Curcumin for Radiation Dermatitis

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ClinicalTrials.gov Identifier: NCT01246973
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Julie Ryan, University of Rochester

Tracking Information
First Submitted Date  ICMJE November 22, 2010
First Posted Date  ICMJE November 24, 2010
Results First Submitted Date  ICMJE January 5, 2016
Results First Posted Date  ICMJE March 7, 2016
Last Update Posted Date March 7, 2016
Study Start Date  ICMJE February 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Mean Radiation Dermatitis Severity Score [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
To evaluate the degree to which curcumin can reduce radiation-induced skin reactions in breast cancer patients receiving radiotherapy. [ Time Frame: 6 weeks ]
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).
Change History Complete list of historical versions of study NCT01246973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Percentage of Subjects With Moist Desquamation [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
How curcumin can prevent or decrease the incidence of moist desquamation, redness and pain at treatment site [ Time Frame: 6 weeks ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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..
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
  • Drug: Placebo
    4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Study Arms  ICMJE
  • Experimental: curcumin
    4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
    Intervention: Drug: Curcumin
  • Placebo Comparator: Placebo
    4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2016)
686
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)
508
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01246973
Other Study ID Numbers  ICMJE URCC 10054
URCC 09005 ( Other Identifier: NCI )
U10CA037420 ( U.S. NIH Grant/Contract )
URCC 10054 ( Other Identifier: University of Rochester )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Ryan, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Julie Ryan, PhD, MPH University of Rochester
PRS Account University of Rochester
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP