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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Mitos Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mitos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00801086
First received: December 1, 2008
Last updated: December 2, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Alopecia
Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)
Drug: alcohol-based gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by Mitos Pharmaceuticals:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: November 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801086

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Jamie Holt    520-694-6000 ext 2970      
Principal Investigator: Baldassarre Stea, MD,PhD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Deborah Smith, RN    215-662-6694      
Principal Investigator: Jim Metz, MD         
Sponsors and Collaborators
Mitos Pharmaceuticals
Investigators
Study Chair: James Metz, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Louis Habash/ President and CEO, Mitos Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00801086     History of Changes
Other Study ID Numbers: MITO 02-03
Study First Received: December 1, 2008
Last Updated: December 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Mitos Pharmaceuticals:
Alopecia
Hair loss
Radiation
Whole brain radiotherapy
Radiation-induced alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases
Ethanol
Tempol
Anti-Infective Agents
Anti-Infective Agents, Local
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Protein Synthesis Inhibitors
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014