search
Back to results

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

Primary Purpose

Alopecia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
7% (w/v) Tempol alcohol-based gel (MTS-01)
alcohol-based gel
Sponsored by
Mitos Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alopecia focused on measuring Alopecia, Hair loss, Radiation, Whole brain radiotherapy, Radiation-induced alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of ArizonaRecruiting
  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

MTS-01 (7% Tempol gel)

Vehicle

Outcomes

Primary Outcome Measures

Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2008
Last Updated
December 2, 2008
Sponsor
Mitos Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00801086
Brief Title
Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mitos Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
Alopecia, Hair loss, Radiation, Whole brain radiotherapy, Radiation-induced alopecia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MTS-01 (7% Tempol gel)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
7% (w/v) Tempol alcohol-based gel (MTS-01)
Intervention Description
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
Intervention Type
Drug
Intervention Name(s)
alcohol-based gel
Intervention Description
200mL gel applied daily prior to radiation dose and removed immediately thereafter
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Metz, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Holt
Phone
520-694-6000
Ext
2970
First Name & Middle Initial & Last Name & Degree
Baldassarre Stea, MD,PhD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Smith, RN
Phone
215-662-6694
First Name & Middle Initial & Last Name & Degree
Jim Metz, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs