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Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

Primary Purpose

Alopecia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compression HeadBand
Sponsored by
Michael Milano, MD,PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alopecia focused on measuring Alopecia, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compression Headband

Arm Description

a compression headband, placed only at the time of irradiation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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?
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?
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?

Full Information

First Posted
October 12, 2012
Last Updated
February 27, 2017
Sponsor
Michael Milano, MD,PhD
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1. Study Identification

Unique Protocol Identification Number
NCT02935569
Brief Title
Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
Official Title
Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Results with 4 subjects suggest a redesign of Compression system is required.
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Milano, MD,PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a pilot feasibility study. The primary objective of this study is to seek preliminary information to answer the following question: 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: Is a temporary compression headband well tolerated in patients undergoing whole brain radiation? If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth? 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
Alopecia, Radiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression Headband
Arm Type
Experimental
Arm Description
a compression headband, placed only at the time of irradiation
Intervention Type
Device
Intervention Name(s)
Compression HeadBand
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation
Description
Does a temporary compression headband cause side effects in patients undergoing whole brain ? Nausea? Headache? Redness? Tingling?
Time Frame
6 weeks
Title
Timing of hair regrowth
Description
If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth?
Time Frame
one year
Title
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
Description
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?
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Milano, MD, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Radiation Oncology, University of Rochester, Med Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers can contact the PI to obtain IPD with collaboration.

Learn more about this trial

Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

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