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

Vanderbilt University Medical Center

Status and phase: Completed; Phase 3

Conditions: Malignant Head and Neck Neoplasm; Radiation-Induced Disorder; Mucositis

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02480114

NCI-2015-00750 (Registry Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

VICC HN 1541 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Arm I Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Drug: Oxycodone/Acetaminophen

Drug: Ibuprofen

Other: Quality-of-Life Assessment

Drug: Fentanyl

Other: Educational Intervention

Drug: Magic Mouthwash

Drug: Hydrocodone/Acetaminophen

Other: Pain Therapy

Arm II Standard of Care Plus Gabapentin

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Drug: Oxycodone/Acetaminophen

Drug: Ibuprofen

Other: Quality-of-Life Assessment

Drug: Fentanyl

Other: Educational Intervention

Drug: Magic Mouthwash

Drug: Hydrocodone/Acetaminophen

Other: Pain Therapy

Drug: Gabapentin