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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Alopecia

Thank you

Trial Information

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


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

Type of Study:

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

Outcome Measure:

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

Outcome Time Frame:

Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.

Safety Issue:

No

Principal Investigator

James Metz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

MITO 02-03

NCT ID:

NCT00801086

Start Date:

November 2008

Completion Date:

June 2010

Related Keywords:

  • Alopecia
  • Alopecia
  • Hair loss
  • Radiation
  • Whole brain radiotherapy
  • Radiation-induced alopecia
  • Alopecia
  • Alopecia Areata

Name

Location

University of ArizonaTucson, Arizona  85724
University of PennsylvaniaPhiladelphia, Pennsylvania  19104