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

NCT02480114 | Completed Phase 3 Results DMC

• 3 other identifiers: VICC HN 1541NCI-2015-00750P30CA068485
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 3 months post-treatment

Secondary Outcomes (2)

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

  Up to 3 months post-treatment

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

  Up to 3 months post-treatment

Study Arms (2)

Arm I Standard of Care

ACTIVE COMPARATOR

Patients receive standard of care 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 treatment to review foundations of oral care and pain management.

Other: Educational Intervention; Other: Pain Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Oxycodone/Acetaminophen; Drug: Hydrocodone/Acetaminophen; Drug: Fentanyl; Drug: Ibuprofen; Drug: Magic Mouthwash

Arm II Standard of Care Plus Gabapentin

EXPERIMENTAL

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

Other: Educational Intervention; Drug: Gabapentin; Other: Pain Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Oxycodone/Acetaminophen; Drug: Hydrocodone/Acetaminophen; Drug: Fentanyl; Drug: Ibuprofen; Drug: Magic Mouthwash

Interventions

Educational Intervention OTHER

Undergo oral care and pain management education session

Also known as: Education for Intervention

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Gabapentin DRUG

Given PO

Also known as: Gralise, Neurontin, 1-(aminomethyl) cyclohexaneacetic Acid, 60142-96-3,

Arm II Standard of Care Plus Gabapentin

Pain Therapy OTHER

Receive usual oral health care

Also known as: Analgesia, Pain Control, Pain Management, Pain

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Questionnaire Administration OTHER

Ancillary studies

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Oxycodone/Acetaminophen DRUG

Analgesia

Also known as: Percocet

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Hydrocodone/Acetaminophen DRUG

Analgesia

Also known as: Lortab, Vicodin

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Fentanyl DRUG

Transdermal Analgesia

Also known as: Duragesic

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Ibuprofen DRUG

NSAID Analgesia

Also known as: Motrin, Advil

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Magic Mouthwash DRUG

Oral Solution to treat mucositis

Also known as: Miracle Mouthwash, First-Mouthwash BLM, First-BXN Mouthwash

Arm I Standard of Care; Arm II Standard of Care Plus Gabapentin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mucositis; Abnormalities, Radiation-Induced

Interventions

Early Intervention, Educational; Educational Status; Methods; Gabapentin; cyclohexaneacetic acid; Analgesia; Pain Management; oxycodone-acetaminophen; acetaminophen, hydrocodone drug combination; Fentanyl; Ibuprofen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Anesthesia and Analgesia; Therapeutics; Disease Management; Patient Care Management; Health Services Administration; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates

Results Point of Contact

• Title: Derek Smith, DDS, PhD
• Organization: Vanderbilt University Medical Center

derek.k.smith@vumc.org

6159367423

Study Officials

• Derek Smith, DDS,PhD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 24, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 18, 2021
• Results First Posted: September 24, 2020

Record last verified: 2021-01

Locations

US (1)