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

NCT ID: NCT00801086

Last Updated: 2008-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alopecia

Keywords

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Alopecia Hair loss Radiation Whole brain radiotherapy Radiation-induced alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

MTS-01 (7% Tempol gel)

Group Type EXPERIMENTAL

7% (w/v) Tempol alcohol-based gel (MTS-01)

Intervention Type DRUG

200mL gel applied daily prior to radiation dose and removed immediately thereafter.

2

Vehicle

Group Type PLACEBO_COMPARATOR

alcohol-based gel

Intervention Type DRUG

200mL gel applied daily prior to radiation dose and removed immediately thereafter

Interventions

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7% (w/v) Tempol alcohol-based gel (MTS-01)

200mL gel applied daily prior to radiation dose and removed immediately thereafter.

Intervention Type DRUG

alcohol-based gel

200mL gel applied daily prior to radiation dose and removed immediately thereafter

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitos Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Mitos Pharmaceuticals, Inc.

Principal Investigators

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James Metz, MD

Role: STUDY_CHAIR

University of Pennsylvania

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jamie Holt

Role: primary

Deborah Smith, RN

Role: primary

Other Identifiers

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MITO 02-03

Identifier Type: -

Identifier Source: org_study_id