Conditions: Radiodermatitis
Keywords: breast cancer radiation dermatitis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

Detailed description:
The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Arms:
arm 1: Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Interventions: intervention 1: Difinsa53 intervention 2: Aquaphor
Intervention descriptions: intervention 1: Difinsa53 cream is applied to one half of radiation field intervention 2: Aquaphor is applied to one half of radiation field

Protocol document: