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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02935569
Other study ID # UCCP12009
Secondary ID
Status Terminated
Phase N/A
First received October 12, 2012
Last updated February 27, 2017
Start date May 2012
Est. completion date August 2014

Study information

Verified date February 2017
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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?


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Dept. of Radiation Oncology, University of Rochester, Med Center Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
Michael Milano, MD,PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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