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Gabapentin for Oropharyngeal Cancer

Q: Has Gabapentin been given the nod from the Food and Drug Administration?

<p>Due to the lack of clinical data confirming <a href="https://www.withpower.com/clinical-trials/gabapentin">Gabapentin</a>'s efficacy, it received a score of 2 on our safety scale. However, there is existing research indicating that this drug may be safe for medical use.</p>

Phase 2

Recruiting

Led By Daniel Haraf, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is only available to patients enrolled in the Optima II study who have Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis. The purpose of the trial is to compare the rates of opioid use at the completion of radiation for patients with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer.

Who is the study for?

This trial is for patients with HPV-related oropharyngeal cancer who are already part of the Optima II study. They must not have had prior gabapentin therapy, severe kidney issues requiring dialysis, or any known allergy to gabapentin.Check my eligibility

What is being tested?

The PROGRESS Trial is testing whether taking gabapentin before radiation can reduce opioid use in patients with painful mouth sores from cancer treatment. It also looks at quality of life, swallowing function, and need for feeding tubes compared to usual care without gabapentin.See study design

What are the potential side effects?

Potential side effects include dizziness, fatigue, coordination problems, and infections. The trial will monitor how often these occur and if they lead to stopping the medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of opioid use at end of radiation treatment

Secondary outcome measures

Differences in chemotherapy-induced peripheral neuropathy symptoms

Differences in head and neck symptoms

Differences in overall quality of life

+5 more

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815

Allergic reaction

100%

80%

60%

40%

20%

Study treatment Arm

Gabapentin

Benzodiazepine

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GabapentinExperimental Treatment1 Intervention

Participants randomized to this arm will receive gabapentin beginning on evening of the first day of radiation treatment at a dose of 600 mg. Gabapentin will continue to be taken twice a day (morning and evening) for the next 4 days of radiation treatment at increasing doses (up to 900 mg). Participants will continue to receive standard best supportive care medications as per their treating physician's recommendation.

Group II: Supportive Care OnlyActive Control1 Intervention

Participants will receive standard best supportive care medications as per their treating physician's recommendation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gabapentin

2013

Completed Phase 4

~1550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,002 Previous Clinical Trials

817,804 Total Patients Enrolled

Daniel Haraf, MDPrincipal InvestigatorUniversity of Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this clinical experiment?

"Clinicaltrials.gov states that this medical trial is actively recruiting patients. It was first published on January 22nd 2018, with the most recent update made on November 12th 2021."

Answered by AI

What prior experiments have been conducted regarding the effectiveness of Gabapentin?

"Currently, 25 clinical trials are running to further understand the efficacy of Gabapentin. Out of those studies, 9 have reached Phase 3 and 67 different medical centres across America are involved in these investigations. The majority of research is based in Columbus, Ohio."

Answered by AI

Has Gabapentin been given the nod from the Food and Drug Administration?

"Due to the lack of clinical data confirming Gabapentin's efficacy, it received a score of 2 on our safety scale. However, there is existing research indicating that this drug may be safe for medical use."

Answered by AI

What principal ailments does Gabapentin treat?

"Gabapentin can be used to treat a variety of neurological afflictions, such as neuralgia, epilepsies, and postherpetic neuralgia."

Answered by AI

What is the current scope of participation in this investigation?

"Indeed, according to information accessed on clinicaltrials.gov we can ascertain that this medical trial is actively recruiting participants. It was published on the 22nd of January 2018 and last modified on the 12th November 2021; it seeks to enrol 46 patients across 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing

2018. "PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03423264.

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