Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain
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
1 other identifier
interventional
16
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedDecember 3, 2008
December 1, 2008
1.1 years
December 1, 2008
December 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
Study Arms (2)
1
EXPERIMENTALMTS-01 (7% Tempol gel)
2
PLACEBO COMPARATORVehicle
Interventions
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
200mL gel applied daily prior to radiation dose and removed immediately thereafter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Arizona
Tucson, Arizona, 85724, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James Metz, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 3, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2009
Study Completion
June 1, 2010
Last Updated
December 3, 2008
Record last verified: 2008-12