Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02935569
• Other study ID #: UCCP12009
• 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
• 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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

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