Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

Study Overview
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Brief Summary
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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
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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: Is a temporary compression headband well tolerated in patients undergoing whole brain radiation? If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth? 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?

Official Title
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Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

Conditions
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Alopecia

Intervention / Treatment
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* Device: Compression HeadBand


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years old. Undergoing whole brain radiation therapy, using lateral opposed fields Total planned radiation prescription dose between 30 Gy and 37.5 Gy in 10 to 15 treatments. Exclusion Criteria: Current complete or near-complete alopecia (natural or chemotherapy-induced) Concurrent or sequential chemotherapy with an agent known to commonly cause alopecia (Adriamycin, Cytoxan, Ifosfamide, Taxol (greater than 50 mg/m2), or Vincristine). Previous Radiation to the Scalp Any active dermatologic disease affecting the scalp, or temporal arteritis History of severe headaches.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compression Headband<br>a compression headband, placed only at the time of irradiation | Device: Compression HeadBand<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 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? | 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? | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia, Radiotherapy