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

NCT ID: NCT00713154

Last Updated: 2008-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-09-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Alopecia

Keywords

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Radiotherapy induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

2

Control Group

Group Type ACTIVE_COMPARATOR

MTS-01

Intervention Type DRUG

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

Interventions

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MTS-01

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitos Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Mitos Pharmaceuticals, Inc.

Other Identifiers

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Mito 02-02

Identifier Type: -

Identifier Source: org_study_id