Opioid therapy vs. multimodal analgesia in head and neck Cancer (OPTIMAL-HN): study protocol for a randomized clinical trial

Table 2 Study Assessment Schedule

Assessments	At Randomization	During RT Treatment (weekly)	Follow-Up (6 weeks ± 2 weeks)	Follow-Up 3 months
History and Physical	X		X	X
Weight Measurement	X	X	X	X
11-NRS Pain Score Documentation	X	Daily Diary ^ǂ	Daily Diary ^ǂ	X
Opioid Use Documentation	X	X ^¥	X ^¥	X
CTC-AE version 5.0	X	X	X	X
EORTC QLQ-C30 & QLQ-HN 43	X	X Last week of RT treatment only		X
Renal and Liver function assessment (CBC, electrolytes, creatinine, AST, ALT, ALP, Bilirubin total & direct, INR, PTT, albumin)	X (≤ 7 days prior to randomization)	X Last week of RT treatment only (in addition to standard weekly bloodwork for patients receiving chemotherapy)	X	X
Pregnancy Test for women of childbearing age	X (≤ 7 days prior to randomization)

RT: Radiation; 11-NRS: 11-Numeric Rating Scale
^ǂ From the time of randomization to the 6-week follow-up, patients will be asked to document daily average 11-NRS Pain scores
^¥ On a weekly basis, pain diaries will be photocopied to ensure data are captured. Opioid use tabulation will take place weekly during radiation treatment by counting empty bottles (not counting pills at that time). The study staff may also meet with participants during a different daily visit for radiation if scheduling does not permit during the weekly Patient Review (PR) clinic visit. At the first follow-up appointment at 6 weeks, the pain diary will be collected, empty bottles will be tabulated, and if there are non-empty bottles, the pills used from those bottles will be counted. At the 3-month follow-up appointment, participants will be asked whether they continue to consume opioids for head and neck mucosal pain

ISSN: 1472-684X