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Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01042938
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : June 20, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
Julie Ryan, University of Rochester

Tracking Information
First Submitted Date  ICMJE January 4, 2010
First Posted Date  ICMJE January 6, 2010
Results First Submitted Date  ICMJE January 26, 2012
Results First Posted Date  ICMJE June 20, 2012
Last Update Posted Date June 25, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
Change History Complete list of historical versions of study NCT01042938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
  • Moist Desquamation at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
    The presence of moist desquamation at the end of radiation treatment was examined between curcumin and placebo treatment groups. We compared the number of participants (or percentage) with moist desquamation between each treatment group.
  • Redness at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
    Redness at radiation treatment site was measured using a CR-400 Colorimeter (Konica Minolta). The colorimeter uses the L*a*b* color scale. We used a* values (redness) which range from 0.0 to 20.0. The lower the number value, the lower amount of redness. Therefore, high number values represent large amounts of redness.
  • Pain at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
    The McGill Pain Questionnaire-Short Form (MPQ-SF) was used to determine the participants pain at treatment site. The MPQ-SF contains three subscales: affective pain, sensory pain, and perceived pain. This outcome measure compared the total pain score (range 0 to 50)and subscale scores (sensory subscale range 0 to 33; affective subscale range 0 to 12; perceived pain subscale 0 to 5) at the end of radiation therapy between the two treatment arms.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
  • Moist Desquamation at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
  • Redness at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
  • Pain at Radiation Treatment Site [ Time Frame: 4-7 weeks (prescribed course of radiation) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Official Title  ICMJE Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Brief Summary Ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. Despite advances in medical technology, radiation therapy still causes severe early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of patients. Important consequences of radiation-induced dermatitis include impairment of the quality of a patient's life due to pain and premature interruption of radiation treatment, which in turn, may be impair good local control of disease. The biological pathways responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural phenolic compound found in both turmeric and curry powders, can prevent or alleviate radiation-induced skin reactions in breast cancer patients receiving radiotherapy.
Detailed Description Specifically, this clinical pilot study will develop data necessary to calculate a sample size for a larger study to be conducted through the National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) mechanism. Specifically, this pilot project will investigate: 1) if curcumin can prevent or alleviate radiation-induced skin reactions in cancer patients receiving radiotherapy and 2) if skin pigmentation, as well as pain and psychophysiological factors, can predict the severity of radiation-induced dermatitis. Potential future research studies may be conducted to identify the biological mechanisms involved in radiation-induced dermatitis and the radioprotective function of curcumin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Curcumin C3 Complex
    Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks)
    Other Name: Curcumin; curcuminoids
  • Drug: Placebo
    Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks)
    Other Name: dicalcium phosphate with yellow food grade dye
Study Arms  ICMJE
  • Active Comparator: Curcumin C3 Complex
    Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
    Intervention: Drug: Curcumin C3 Complex
  • Placebo Comparator: Placebo
    Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
    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: May 17, 2012)
35
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2010)
30
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.
  • Participants must be at least 21 years of age.
  • Participants must not be pregnant.
  • Participants can be from any racial or ethnic origin.
  • Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.
  • Participants with in situ breast cancer are eligible.
  • Participants who are prescribed concurrent hormone treatment with radiation treatment are eligible.
  • Participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or Canadian (2.2-2.5 Gy per session)irradiation fractionation.
  • A time period of three weeks must elapse after chemotherapy and surgery before beginning the study.
  • The total dose prescribed to the whole breast should be 50 Gy or greater.
  • Participants must be able to understand English and able to complete assessment forms (all assessment forms are in English).
  • Participants must be able to swallow medication.
  • Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed either PRN or prophylactically.
  • Participant must give informed consent.

Exclusion Criteria:

  • Patients with bilateral breast cancer are not eligible.
  • Patients who have had previous radiation therapy to the breast or chest are not eligible.
  • Patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible.
  • Patients who will be receiving treatment with Herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g. Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation therapy are not eligible.
  • Patients cannot have had breast reconstructions, implants, and/or expanders.
  • Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not eligible.
  • Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible.
  • Patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than 75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e., greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e., greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e., greater than 2x ULN).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01042938
Other Study ID Numbers  ICMJE URCC1106
5KL2RR024136-03 ( U.S. NIH Grant/Contract )
05-238-80 ( Other Grant/Funding Number: Dermatology Foundation )
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 Not Provided
Investigators  ICMJE
Principal Investigator: Julie L Ryan, PhD, MPH University of Rochester Medical Center & Wilmot Cancer Center
Study Chair: Julie L Ryan, PhD, MPH University of Rochester Medical Center & Wilmot Cancer Center
Study Chair: Alice P Pentland, MD University of Rochester Medical Center & Wilmot Cancer Center
Study Chair: Marilyn Ling, MD University of Rochester Medical Center & Wilmot Cancer Center
PRS Account University of Rochester
Verification Date June 2012

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