Trial | NCT00713154  Report issue

Title

Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy
A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    mts-01 ...

  • Study Participants

    16
The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy
Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy
Study Started
Apr 30
2007
Primary Completion
Sep 30
2007
Study Completion
Sep 30
2008
Anticipated
Last Update
Jul 11
2008
Estimate

Drug MTS-01

MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment

Drug Placebo

Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment

1 Placebo Comparator

Placebo group

2 Active Comparator

Control Group

Criteria 

Inclusion Criteria:

is >/= 18 years of age
Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
has signed the HIPAA authorization

Exclusion Criteria:

-
No Results Posted