Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy

Phase 2TerminatedNCT00713154

Mitos Pharmaceuticals16 enrolled

Overview

The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy

Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Alopecia

Interventions

MTS-01DRUG

MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment

PlaceboDRUG

Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * is \>/= 18 years of age * Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required * Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol * has signed the HIPAA authorization Exclusion Criteria: \-

Outcomes

Primary Outcomes

Investigator assessment of hair loss using a 10 point scale

Time frame: up to 12 weeks

Secondary Outcomes

A time to event analysis of the hair loss

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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