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

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Fentanyl; Gabapentin; gamma-Aminobutyric Acid; Hydrocodone; Ibuprofen; Oxycodone

Criteria

Inclusion Criteria:

• Histologically proven cancer of the head and neck cancer

• Stage 3 or 4

• Planned primary or adjuvant chemoradiation therapy

• Willing and able to provide informed consent

• English speaking

Exclusion Criteria:

• Currently on gabapentin

• Prior non-tolerance of gabapentin

• History of seizure disorder