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

Mitos Pharmaceuticals16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Alopecia

Interventions

7% (w/v) Tempol alcohol-based gel (MTS-01)DRUG

200mL gel applied daily prior to radiation dose and removed immediately thereafter.

alcohol-based gelDRUG

200mL gel applied daily prior to radiation dose and removed immediately thereafter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Arizona

Tucson, Arizona, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.

Time frame: Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.

Data from ClinicalTrials.gov

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