Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 8, 2021

Primary Completion Date

April 4, 2024

Study Completion Date

April 4, 2024

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Buprenorphine

Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.

DRUG

Tramadol

Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.

DEVICE

Oral Mucositis (OM) Pain App

"Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.~Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels."

Trial Locations (1)

53226

Froedtert & the Medical College of Wisconsin, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER