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

NCT ID: NCT01042938

Last Updated: 2012-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Curcumin C3 Complex

Intervention Type: DRUG

Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Placebo

Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Interventions

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 Type: 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)

Intervention Type: DRUG

Other Intervention Names

Curcumin; curcuminoids; dicalcium phosphate with yellow food grade dye

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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Julie Ryan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie L Ryan, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Medical Center & Wilmot Cancer Center

Julie L Ryan, PhD, MPH

Role: STUDY_CHAIR

University of Rochester Medical Center & Wilmot Cancer Center

Alice P Pentland, MD

Role: STUDY_CHAIR

University of Rochester Medical Center & Wilmot Cancer Center

Marilyn Ling, MD

Role: STUDY_CHAIR

University of Rochester Medical Center & Wilmot Cancer Center

Locations

University of Rochester Medical Center & Wilmot Cancer Center

Rochester, New York, United States

Countries

United States

Other Identifiers

5KL2RR024136-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05-238-80

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

URCC1106

Identifier Type: -

Identifier Source: org_study_id