RayGel-An Alternative for Skin Care During External Beam Radiation
This study is for the patient with breast cancer. To take part in this study, external beam radiation therapy needs to be part of the treatment plan. Reduced glutathione, an ingredient of RayGel™, has been helpful in decreasing some radiation therapy side effects to the skin.
Reduced glutathione plays a vital role in both making DNA and cell repair. This study will measure if RayGel decreases skin reaction in breast cancer patients treated with external beam radiation therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Prospective Blinded Randomized Study; RayGel Versus Placebo-an Alternative for Skin Care During External Beam Radiation.|
- Reduction in skin damage [ Time Frame: Start of radiation therapy until completion ] [ Designated as safety issue: No ]Skin reaction scale along with evaluation by radiation oncologist at weekly intervals from start of radiation therapy until completion of radiation.
|Study Start Date:||October 2004|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Group A, RayGel Topical Cream
RayGel Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.
|Drug: Reduced glutathione|
Placebo Comparator: Arm B Placebo Topical Cream
Placebo Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00266331
|United States, Oregon|
|Legacy Health System|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Thomas Johnson, MD||Legacy Health System|