At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
In Brief
A Phase 3 clinical trial evaluating Educational Intervention, Gabapentin, and 8 other interventions for Malignant Head and Neck Neoplasm and 2 related conditions. Completed, enrolled 79 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Undergo oral care and pain management education session
Given PO
Receive usual oral health care
Ancillary studies
Ancillary studies
Analgesia
Analgesia
Transdermal Analgesia
NSAID Analgesia
Oral Solution to treat mucositis