drugset / Trial / NCT02480114

Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy

NCT02480114

RandomizedParallel-groupOpen-labelSupportive care

Summary

This randomized phase III trial studies how well gabapentin plus standard of care work compares to standard of care without Gabapentin in preventing inflammation of the mucous membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and neck may cause a burn involving the inside of the mouth, throat, and nasal passages, resulting in pain. Gabapentin may help prevent (or minimize) pain associated with radiation-induced mucositis in patients with head and neck cancer.

Timeline

Start
2015-07
Primary completion
2019-09
Completion
2020-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Small molecule Oral
Background Fentanyl Other / unclassified Other
Background Hydrocodone/Acetaminophen Unknown
Background Ibuprofen Small molecule
Background Oxycodone/Acetaminophen Unknown