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Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

NCT ID: NCT02935569

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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?

Conditions

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Alopecia

Keywords

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Alopecia Radiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Compression Headband

a compression headband, placed only at the time of irradiation

Group Type EXPERIMENTAL

Compression HeadBand

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michael Milano, MD,PhD

OTHER

Sponsor Role lead

Responsible Party

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Michael Milano, MD,PhD

Assoc Professor, Radiation Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Milano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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UCCP12009

Identifier Type: -

Identifier Source: org_study_id