Clinical trial NCT02935569: 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
Overall status: TERMINATED
Phase: NA
Conditions: Alopecia
Keywords: Alopecia
Radiotherapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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:

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?

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.

Primary outcomes:
measure: 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
timeFrame: baseline to 6 weeks
Secondary outcomes:
measure: Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation
timeFrame: 6 weeks
measure: Timing of hair regrowth
timeFrame: one year
measure: 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
timeFrame: 1 hour
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Dept. of Radiation Oncology, University of Rochester, Med Center
state: New York
Study officials:
affiliation: University of Rochester
name: Michael Milano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: