Trial Information

Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients

OBJECTIVES:

Primary

- To examine the efficacy of curcumin in preventing and/or reducing the severity of
radiation-induced dermatitis site in patients with breast cancer.

Secondary

- To determine the efficacy of curcumin in preventing and/or reducing moist desquamation
in radiation treatment site in patients with breast cancer.

- To determine the efficacy of curcumin in preventing and/or reducing redness in
radiation treatment site in patients with breast cancer.

- To determine the efficacy of curcumin in preventing and/or reducing pain in radiation
treatment site in breast cancer patients.

- To determine whether curcumin improves the quality of life of patients with breast
cancer undergoing radiotherapy.

- To investigate potential prognostic factors for the prediction of radiation-induced
dermatitis, including race/ethnicity, Fitzpatrick skin type, skin pigmentation
(baseline erythema index & baseline melanin index), body mass index (BMI), previous
skin problems, patient expectations of radiotherapy, blood cytokine levels (baseline),
pain at treatment (baseline SF-MPQ-2), and various symptoms from Symptom Inventory (SI)
(baseline pain at site, distress, nausea, disturbed sleep, fatigue, and mood).
(exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to CCOP site and
radiotherapy treatment regimen (standard fractions vs Canadian fractions). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral curcumin C3 Complex® three times daily during radiotherapy
(RT) (4-5 weeks of standard RT OR 3-4 weeks of Canadian RT) and for 1 week after
completion of RT.

- Arm II: Patients receive oral placebo three times daily during RT (4-5 weeks standard
RT OR 3-4 weeks Canadian RT) and for 1 week after completion of RT.

Some patients undergo blood sample collection at baseline and at 1 week after completion of
treatment for curcumin and cytokine level studies.

Patients complete the Fitzpatrick Skin Typing Test, the Symptom Inventory Survey, the
Short-Form McGill Pain Questionnaire (SF-MPQ), and the Skindex-29 Questionnaire at baseline
and periodically during study. Patients also undergo digital photographs of the irradiated
area periodically. Photographs are analyzed by the Derivation of Erythema Index and the
Melanin Index.

After completion of study therapy, patients are followed up for 1 month.