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
Recruitment status was Recruiting
Sponsor:
Mitos Pharmaceuticals
Information provided by:
Mitos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00801086
First received: December 1, 2008
Last updated: December 2, 2008
Last verified: December 2008
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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
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 Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical Ethanol Tempol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Radiation-Protective Agents Neuroprotective Agents |
ClinicalTrials.gov processed this record on June 17, 2013