Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

NCT02531906 | Completed Phase 1 DMC

• 2 other identifiers: I 262314NCI-2015-01338
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help relieve moderate or severe pain caused by head and neck cancer during and after chemoradiation therapy.

Conditions

Head and Neck Squamous Cell Carcinoma; Pain; Stomatitis

Outcome Measures

Primary Outcomes (3)

• Change in pain levels via Oral Mucositis Daily Questionnaire (OMDQ), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30, Head and Neck Quality of Life Survey, and physical evaluations

  Evaluated using a repeated measures model. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

  Baseline to up to 24 months

• Incidence of side effects or drug intolerance

  Will be graded and recorded. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate. The frequency of toxicities will be tabulated by grade by treatment arm.

  Up to 24 months

• Proportion of patients who require higher equivalents of narcotic support added to their analgesia regimen in each arm

  Each patient requiring rescue medication for breakthrough or refractory pain will be counted as a failure for that specific regimen. At the end of the trial, number of failures will be compared between the two treatment arms using Fisher's exact test. Total amount of opioid intake mean will be compared using a t-test between the two arms. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate

  Up to 24 months

Secondary Outcomes (2)

• Change in oral mucositis rating scores during and after CRT, using the OMDQ

  Baseline to up to 24 months

• Change in quality of life rating scores during and after CRT, using the EORTC QLQ-C30 and H&N35

  Baseline to up to 24 months

Other Outcomes (1)

• Change in patient hydration and nutrition using the OMDQ

  Baseline to up to 24 months

Study Arms (2)

Arm I (gabapentin)

EXPERIMENTAL

Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy. All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Drug: Gabapentin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (gabapentin, methadone, oxycodone)

EXPERIMENTAL

Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy. All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Drug: Gabapentin; Drug: Methadone Hydrochloride; Drug: Oxycodone Hydrochloride; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Gabapentin DRUG

Given PO

Also known as: Gralise, Neurontin

Arm I (gabapentin); Arm II (gabapentin, methadone, oxycodone)

Methadone Hydrochloride DRUG

Given PO

Also known as: Adanon, Althose, Dolophine, Methadose

Arm II (gabapentin, methadone, oxycodone)

Oxycodone Hydrochloride DRUG

Given PO

Also known as: Oxecta, OxyContin, Roxicodone

Arm II (gabapentin, methadone, oxycodone)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (gabapentin); Arm II (gabapentin, methadone, oxycodone)

Questionnaire Administration OTHER

Ancillary studies

Arm I (gabapentin); Arm II (gabapentin, methadone, oxycodone)

Eligibility Criteria

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

You may qualify if:

• Patients who are eligible for chemoradiation therapy of the head and neck
• Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal
• Have a clinical stage II-IV head and neck carcinoma
• Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Ability to swallow and retain oral medication or take through a feeding tube
• Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if:

• Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer
• Patients with known brain metastases will be excluded from this clinical trial
• Any patients prescribed medications for chronic pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs
• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or nursing female patients
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
• Received an investigational agent within 30 days prior to enrollment
• Patients on medications that prolong QT interval
• Patients on dialysis or with transplanted organs
• Patients already enrolled on other studies of systemic pain control agents

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Pain; Stomatitis

Interventions

Gabapentin; Methadone; Amidines; Oxycodone

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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; Ketones; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Anurag Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 25, 2015
• Study Start: April 24, 2015
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2018
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)