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Results with 4 subjects suggest a redesign of Compression system is required.
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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compression Headband | Experimental | a compression headband, placed only at the time of irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression HeadBand | Device |
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. |
| 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.
| baseline to 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Milano, MD, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Radiation Oncology, University of Rochester, Med Center | Rochester | New York | 14642 | United States |
Researchers can contact the PI to obtain IPD with collaboration.
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |