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

Completed · Phase 3

Conditions studied: Malignant Head and Neck Neoplasm, Mucositis, Radiation-Induced Disorder

In brief

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.

Key facts

Study ID

NCT02480114

Run by

Vanderbilt-Ingram Cancer Center

People needed

79

Starts

2015-07-01

Expected to finish

2020-01-01

Last updated by the study team

2021-02-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Currently on gabapentin
• Prior non-tolerance of gabapentin
• History of seizure disorder

Where it is running

• Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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