Vanderbilt Clinical Trials

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

Purpose

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

Eligibility

Eligible Ages: Over 21 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Arm I Standard of Care	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 Undergo oral care and pain management education session Other names: Education for Intervention Other: Pain Therapy Receive usual oral health care Other names: Analgesia Pain Control Pain Management Pain Other: Quality-of-Life Assessment Ancillary studies Other names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Drug: Oxycodone/Acetaminophen Analgesia Other names: Percocet Drug: Hydrocodone/Acetaminophen Analgesia Other names: Lortab Vicodin Drug: Fentanyl Transdermal Analgesia Other names: Duragesic Drug: Ibuprofen NSAID Analgesia Other names: Motrin Advil Drug: Magic Mouthwash Oral Solution to treat mucositis Other names: Miracle Mouthwash First-Mouthwash BLM First-BXN Mouthwash
Experimental 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 PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.	Other: Educational Intervention Undergo oral care and pain management education session Other names: Education for Intervention Drug: Gabapentin Given PO Other names: Gralise Neurontin 1-(aminomethyl) cyclohexaneacetic Acid, 60142-96-3, Other: Pain Therapy Receive usual oral health care Other names: Analgesia Pain Control Pain Management Pain Other: Quality-of-Life Assessment Ancillary studies Other names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Drug: Oxycodone/Acetaminophen Analgesia Other names: Percocet Drug: Hydrocodone/Acetaminophen Analgesia Other names: Lortab Vicodin Drug: Fentanyl Transdermal Analgesia Other names: Duragesic Drug: Ibuprofen NSAID Analgesia Other names: Motrin Advil Drug: Magic Mouthwash Oral Solution to treat mucositis Other names: Miracle Mouthwash First-Mouthwash BLM First-BXN Mouthwash

More Details

Status: Completed
Sponsor: Vanderbilt-Ingram Cancer Center

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.