High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial
Categories (click each to see list of all clinical trials associated with that category): Head & Neck (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Zhen, Weining
Contact Information:
Trevor Beard
tbeard@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06992427?term=NCT06992427&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To determine whether prophylactic high dose gabapentin, titrated to a dose of 3600 mg (1200 mg three times per day [TID]), is superior to placebo in increasing the proportion of patients not needing opiates while undergoing chemoradiation therapy.
SECONDARY OBJECTIVES:
I. To determine whether prophylactic high dose gabapentin is superior to placebo in prolonging the time to first opioid use while undergoing chemoradiation therapy.
II. To determine whether prophylactic high dose gabapentin is superior to placebo in improving patient reported pain scores using the 0-10 numerical rating scale (NRS) from baseline to 4 weeks after the end of chemoradiation therapy.
EXPLORATORY OBJECTIVES:
I. To explore the duration of opioid use from the time of initiation to cessation by arm as well as describe the proportion of patients remaining on opioids at 3 months, 6 months, and 1 year by arm.
II. To explore the trajectory of patient reported symptom and quality of life outcomes using the Oral Mucositis Weekly Questionnaire (OMWQ) by arm.
III. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-30) by arm.
IV. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck-43 (EORTC
QLQ-H&N43) by arm.
V. To evaluate the adverse event profiles of prophylactic high dose gabapentin versus placebo.
VI. To assess the tolerance of high dose gabapentin. VII. To explore the trajectory of patient health using patient body mass index (BMI) and creatinine, absolute neutrophil count (ANC) as routinely obtained by arm.
VIII. To describe the incidence of feeding tube requirement during and after chemoradiation therapy by arm.
IX. To describe the dose of prescribed opioids standardized using the Morphine Milligram Equivalent calculator by arm.