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Could an antidepressant ease cancer treatment pain? new study investigates

NCT ID NCT03574792

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding venlafaxine (an antidepressant) to a standard pain regimen of gabapentin, methadone, and oxycodone could better control pain in 62 people with head and neck cancer undergoing chemoradiation. The study measured pain scores and side effects during and after treatment. Results may help improve pain management and quality of life for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Venlafaxine (an antidepressant) added to gabapentin, methadone, and oxycodone
What this could lead to
If it works, this could point toward a better way to manage severe pain during head and neck cancer treatment, potentially improving quality of life.
What could go wrong
This is a small, early-phase study (62 people) that is already completed, so results may not apply to everyone. Adding venlafaxine may cause side effects like nausea or dizziness without improving pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

62 people

The number who actually took part.

Started

May 2018

Finished

Nov 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.