Clinical trial NCT01246973: Oral Curcumin for Radiation Dermatitis
Official title: Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Radiation-induced Dermatitis
Keywords: Oral Curcumin
Radiation Dermatitis
Breast Cancer Patients
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-24
Enrollment: 686
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Radiation Dermatitis Severity Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of Subjects With Moist Desquamation
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Julie Ryan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: