Clinical trial NCT01042938: Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Official title: Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Radiation dermatitis in breast cancer patients
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 35
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients
timeFrame: 4-7 weeks (prescribed course of radiation)
Secondary outcomes:
measure: Moist Desquamation at Radiation Treatment Site
timeFrame: 4-7 weeks (prescribed course of radiation)
measure: Redness at Radiation Treatment Site
timeFrame: 4-7 weeks (prescribed course of radiation)
measure: Pain at Radiation Treatment Site
timeFrame: 4-7 weeks (prescribed course of radiation)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center & Wilmot Cancer Center
state: New York
Study officials:
affiliation: University of Rochester Medical Center & Wilmot Cancer Center
name: Julie L Ryan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester Medical Center & Wilmot Cancer Center
name: Julie L Ryan, PhD, MPH
role: STUDY_CHAIR
affiliation: University of Rochester Medical Center & Wilmot Cancer Center
name: Alice P Pentland, MD
role: STUDY_CHAIR
affiliation: University of Rochester Medical Center & Wilmot Cancer Center
name: Marilyn Ling, MD
role: STUDY_CHAIR
References: