Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

NCT02935569 | Terminated

• 1 other identifier: UCCP12009
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alopecia

Keywords

Alopecia; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation

  6 weeks

• 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

  1 hour

Study Arms (1)

Compression Headband

EXPERIMENTAL

a compression headband, placed only at the time of irradiation

Device: Compression HeadBand

Interventions

Compression HeadBand DEVICE

* 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.

Compression Headband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Milano, MD,PhD: lead

Study Sites (1)

Dept. of Radiation Oncology, University of Rochester, Med Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Milano, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Professor, Radiation Oncology

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 17, 2016
• Study Start: May 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)