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

December 2, 2008 updated by: Mitos Pharmaceuticals

Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
          • Jamie Holt
          • Phone Number: 2970 520-694-6000
        • Principal Investigator:
          • Baldassarre Stea, MD,PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Deborah Smith, RN
          • Phone Number: 215-662-6694
        • Principal Investigator:
          • Jim Metz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
MTS-01 (7% Tempol gel)
Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
PLACEBO_COMPARATOR: 2
Vehicle
Drug: alcohol-based gel
200mL gel applied daily prior to radiation dose and removed immediately thereafter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitos Pharmaceuticals

Investigators

  • Study Chair: James Metz, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

December 1, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2008

Last Update Submitted That Met QC Criteria

December 2, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITO 02-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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