Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain

Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.

Inclusion Criteria:

• Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.
• Hair that covers the scalp and is at least 1/4 inch in length

Exclusion Criteria:

• Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
• Pre-existing alopecia
• Previous brain radiotherapy
• scalp metastases or scalp wounds
• use of hair dyes