Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy

NCT03574792 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: I 61117NCI-2018-01055
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well gabapentin, methadone, and oxycodone with or without venlafaxine hydrochloride work in managing pain in participants with stage II-IV squamous cell head and neck cancer undergoing chemoradiation therapy. Gabapentin may reduce the need for these pain medications if given at the start of radiation therapy. Methadone and oxycodone may help relieve pain caused by cancer. Venlafaxine hydrochloride may prevent or improve pain caused by cancer. It is now yet known whether giving gabapentin, methadone, and oxycodone with venlafaxine hydrochloride will work better in managing pain in participants with squamous cell head and neck cancer undergoing chemoradiation therapy.

Conditions

Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

Outcome Measures

Primary Outcomes (1)

• Pain-reduction Effects of Adding Venlafaxine to a Regimen of Gabapentin and Methadone to Control Pain During and After Chemoradiation

  To assess the pain-reduction effects of adding venlafaxine to a regimen of gabapentin and methadone to control pain during and after chemoradiation, per European Organization for Research and Treatment of Cancer (EORTC) Head and Neck Cancer Module (EORTC QLQ-H and N35). The pain scores range between 0 and 100, with higher values represent worse outcomes. The pain scores (mean/standard deviation) of baseline and end of treatment (week 7) are reported.

  Participants were assessed up to 24 months after enrollment, change in score from baseline at week 7 reported

Secondary Outcomes (1)

• Incidence of Adverse Events of Pain Regimen Per Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0)

  Up to 24 months

Study Arms (2)

Arm I (gabapentin, methadone, oxycodone)

ACTIVE COMPARATOR

Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

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

Arm II (gabapentin, methadone, oxycodone, venlafaxine)

EXPERIMENTAL

Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

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

Interventions

Gabapentin DRUG

Given PO

Also known as: Gralise, Neurontin

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

Methadone DRUG

Given PO

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

Oxycodone DRUG

Given PO

Also known as: Oxycodone SR

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

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

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

Questionnaire Administration OTHER

Ancillary studies

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

Venlafaxine DRUG

Given PO

Arm II (gabapentin, methadone, oxycodone, venlafaxine)

Venlafaxine Hydrochloride Extended Release DRUG

Given PO

Also known as: Effexor XR, Venlafaxine HCl ER

Arm II (gabapentin, methadone, oxycodone, venlafaxine)

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.
• Patients must have adequate renal function to undergo platinum based chemotherapy. This will mean a baseline creatinine level (Cr) no greater than 1.5 times the upper limit of normal.
• 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/or retain oral or per tube medication.
• 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 because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Any patients prescribed medications for chronic and/or long term pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs. Acute post-op medications are allowed if the patient has discontinued them prior to initiating study.
• Any patients prescribed a selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), monoamine oxidase inhibitors (MAOIs), dextromethorphan, triptan, tryptophan supplements, IV methylene blue, linezolid or any other medication that may increase risk of serotonin syndrome, as deemed by the investigator?s opinion.
• Any patients with suspected or known, current or recent (within last 5 years) use of cocaine, amphetamines, lysergic acid diethylamide (LSD), 3,4- methylenedioxymethamphetamine (MDMA), or any other drug of abuse that may increase risk of serotonin syndrome, as deemed by the Investigator?s opinion.
• Any patients with history of suicide-related events, or those exhibiting a significant degree of suicidal ideation.
• Patients with acute narrow-angle glaucoma.
• 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 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

Interventions

Gabapentin; Methadone; Oxycodone; Venlafaxine Hydrochloride

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; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Lipids

Results Point of Contact

• Title: Katy Wang, MA. Biostatistican
• Organization: Roswell Park Cancer Comprehensive Center

KATY.WANG@ROSWELLPARK.ORG

7168451300

Study Officials

• Anurag Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 2, 2018
• Study Start: May 3, 2018
• Primary Completion: April 19, 2021
• Study Completion: November 11, 2021
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-04

Locations

US (1)