Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy

Michael Milano, MD,PhD

Status

Terminated

Conditions

Alopecia

Treatments

Device: Compression HeadBand

Study type

Interventional

Funder types

Other

Identifiers

NCT02935569

UCCP12009

Details and patient eligibility

About

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.

Full 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?

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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.