Trials / Terminated
TerminatedNCT02935569
Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Michael Milano, MD,PhD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression headband will decrease the percentage of patients with significant hair loss following radiation.
Detailed description
This is a pilot feasibility study. The primary objective of this study is to seek preliminary information to answer the following question: 1. Does a compression headband, placed only at the time of irradiation, reduce the incidence of significant hair loss after whole brain radiation, as compared to historical controls? This study will also seek to answer these secondary questions: 2. Is a temporary compression headband well tolerated in patients undergoing whole brain radiation? 3. If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth? 4. In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Compression HeadBand | * commercially available office rubber bands (Alliance® Sterling Rubber Bands, Size 105) OR commercially available medical non-latex bands (Allegience® 1" x 18" x .025") with Velcro adhesion * Plastics disks, hollow (3.5 cm diameter, by 1 cm height) Two bands will be placed just behind the ears laterally, and over the occipital protuberance posteriorly. The plastic inserts will be placed in the temporal fossae bilaterally, under the band to provide adequate tension on the temporal artery. |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2016-10-17
- Last updated
- 2017-02-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02935569. Inclusion in this directory is not an endorsement.