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

Sponsor

Mitos Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00801086

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Nov 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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