Phase 3
N=686
Oral Curcumin for Radiation Dermatitis
Radiation-induced Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01246973 ↗Enrolled (actual)
686
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Mean Radiation Dermatitis Severity Score — 2.02; 1.99 units on a scale — p=0.6555
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Curcumin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Radiation Dermatitis Severity Score |
2.02; 1.99 | 0.6555 |
| SECONDARY Percentage of Subjects With Moist Desquamation |
9.541; 12.203 | 0.3504 |
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..
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
Data sourced from ClinicalTrials.gov (NCT01246973). 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.