Phase 2
N=35
Curcumin for the Prevention of Radiation-induced Dermatitis in Breast Cancer Patients
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01042938 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients — 2.6; 3.4 units on a scale — p=0.0077
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Curcumin C3 Complex (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients |
2.6; 3.4 | 0.0077 sig |
| SECONDARY Moist Desquamation at Radiation Treatment Site |
4; 14 | 0.0022 sig |
| SECONDARY Redness at Radiation Treatment Site |
4.52; 6.06 | 0.145 |
| SECONDARY Pain at Radiation Treatment Site |
5.71; 3.50; 4.07; 2.25; 0.50; 0.50 | 0.218 |
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).
Data sourced from ClinicalTrials.gov (NCT01042938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.