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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00713154
Recruitment Status : Terminated (Major planned study protocol modifications)
First Posted : July 11, 2008
Last Update Posted : July 11, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Alopecia Drug: MTS-01 Drug: Placebo Phase 2

Detailed 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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
Study Start Date : April 2007
Primary Completion Date : September 2007
Estimated Study Completion Date : September 2008
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Placebo group
Drug: Placebo
Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
Active Comparator: 2
Control Group
Drug: MTS-01
MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment


Outcome Measures

Primary Outcome Measures :
  1. Investigator assessment of hair loss using a 10 point scale [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. A time to event analysis of the hair loss [ Time Frame: up to 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

More Information

Responsible Party: Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00713154     History of Changes
Other Study ID Numbers: Mito 02-02
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: July 11, 2008
Last Verified: July 2008

Keywords provided by Mitos Pharmaceuticals:
Radiotherapy
induced

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Tempol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Protective Agents
Neuroprotective Agents