NCT00713154

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 11, 2008

Status Verified

July 1, 2008

Enrollment Period

5 months

First QC Date

July 9, 2008

Last Update Submit

July 10, 2008

Conditions

Alopecia

Keywords

Radiotherapyinduced

Outcome Measures

Primary Outcomes (1)

  • Investigator assessment of hair loss using a 10 point scale

    up to 12 weeks

Secondary Outcomes (1)

  • A time to event analysis of the hair loss

    up to 12 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

2

ACTIVE COMPARATOR

Control Group

Drug: MTS-01

Interventions

MTS-01DRUG

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

2
PlaceboDRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

April 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2008

Last Updated

July 11, 2008

Record last verified: 2008-07