Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Dermatitis; Radiodermatitis
Intervention: Curcumin C3 Complex; Placebo
Intervention description: Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks); Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks)
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Radiation dermatitis in breast cancer patients

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.
    

Eligibility criteria:

        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).