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

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.

Conditions

• Malignant Head and Neck Neoplasm
• Mucositis
• Radiation-Induced Disorder

Interventions

OTHER

Educational Intervention

Undergo oral care and pain management education session

DRUG

Gabapentin

Given PO

OTHER

Pain Therapy

Receive usual oral health care

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Oxycodone/Acetaminophen

Analgesia

DRUG

Hydrocodone/Acetaminophen

Analgesia

DRUG

Fentanyl

Transdermal Analgesia

DRUG

Ibuprofen

NSAID Analgesia

DRUG

Magic Mouthwash

Oral Solution to treat mucositis

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Derek Smith, DDS,PhD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2019-09-30

Completion

2020-01-31

Countries

• United States

Study Locations