An interventional study of Compression HeadBand in Alopecia, sponsored by Michael Milano, MD,PhD. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by Michael Milano, MD,PhD · Not applicable, Interventional, and Supportive care
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.
This is a pilot feasibility study. The primary objective of this study is to seek preliminary information to answer the following question:
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:
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 4 is below the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →This is the only study on the registry with Michael Milano, MD,PhD as lead sponsor.
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Exclusion Criteria:
a compression headband, placed only at the time of irradiation
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.
Change in Hair loss defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3
The primary outcome of this study will be the presence of "significant hair loss" by 6 weeks after the completion of whole brain radiation. This will be defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3. The amount of hair loss will be evaluated at the following time points. * Before whole brain radiation * six weeks following radiation
Time frame: baseline to 6 weeks
Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation
Does a temporary compression headband cause side effects in patients undergoing whole brain ? Nausea? Headache? Redness? Tingling?
Time frame: 6 weeks
Timing of hair regrowth
If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?
Time frame: one year
Acute hypoxia in the scalp of normal volunteers caused by compression headband (if present, to what degree?) as measured by a transcutaneous oxygen pressure monitor
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?
Time frame: 1 hour
Plan to share: Yes — Researchers can contact the PI to obtain IPD with collaboration.
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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