Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

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

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.

Study Overview

• Status: Terminated
• Conditions: Alopecia
• Intervention / Treatment: Device: Compression HeadBand

Detailed 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?

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Dept. of Radiation Oncology, University of Rochester, Med Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Compression Headband; a compression headband, placed only at the time of irradiation

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Michael Milano, MD,PhD
• Investigators: Principal Investigator: Michael Milano, MD, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Radiotherapy; Alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: UCCP12009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers can contact the PI to obtain IPD with collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No