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

Mitos Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Alopecia

Treatments: Drug: MTS-01; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713154

Mito 02-02

Details and patient eligibility

About

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

Full description

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo group

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

Control Group

Treatment:

Drug: MTS-01