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
Phase 3
Completed
79 enrolled
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | — | Oral |
| Background | Fentanyl | Other / unclassified | — | Other |
| Background | Hydrocodone/Acetaminophen | Unknown | — | — |
| Background | Ibuprofen | Small molecule | — | — |
| Background | Oxycodone/Acetaminophen | Unknown | — | — |