Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Head and Neck Neoplasm Abnormalities, Radiation-Induced Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Neoplasms Mouth Diseases Mucositis Neoplasms Neoplasms by Site Radiation Injuries Radiation-Induced Disorder Stomatognathic Diseases Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

Primary Objectives:

  • To determine whether gabapentin used as a preventive measure during chemoradiation can reduce radiation-induced mucositis associated pain in head and neck cancer patients as measured by: 1) pain scores on the Vanderbilt Head and Neck Symptom Survey (VHNSS version 2.), and 2) analgesic use.

Secondary Objectives:

  • To assess the safety (grade 3 or 4 adverse events) and tolerability of using gabapentin (discontinuation of drug due to side effects - yes or no)
  • To correlate pain severity with frequency and severity of general systemic symptoms.

Exploratory Objectives:

  • To determine whether pain control is associated with weight loss (in pounds) and duration of use of percutaneous endoscopic gastrostomy utilization (in days).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Standard of Care (usual care) - Patients receive consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of chemoradiation treatment to review foundations of oral care and pain management.

ARM II: Standard of Care plus Gabapentin - Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin orally (PO) three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.

After completion of study treatment, patients are followed up monthly for 3 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Undergo oral care and pain management education session

Other names: Education for Intervention

Gabapentin

Drug

Given PO

Other names: Gralise, Neurontin, 1-(aminomethyl) cyclohexaneacetic Acid, 60142-96-3,

Pain Therapy

Other

Receive usual oral health care

Other names: Analgesia, Pain Control, Pain Management, Pain

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Oxycodone/acetaminophen

Drug

Analgesia

Other names: Percocet

Hydrocodone/Acetaminophen

Drug

Analgesia

Other names: Lortab, Vicodin

Fentanyl

Drug

Transdermal Analgesia

Other names: Duragesic

Ibuprofen

Drug

NSAID Analgesia

Other names: Motrin, Advil

Magic Mouthwash

Drug

Oral Solution to treat mucositis

Other names: Miracle Mouthwash, First-Mouthwash BLM, First-BXN Mouthwash

Primary outcomes

  1. Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))

    Time frame: Up to 3 months post-treatment

    The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain.

Secondary outcomes

  1. Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)

    Time frame: Up to 3 months post-treatment

    Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome.

  2. Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)

    Time frame: Up to 3 months post-treatment

    Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jun 24, 2015
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.