Gabapentin for Pain in Head and Neck Cancer

(HOPE Trial)

Recruiting at 5 trial locations

Overseen By Nancy Garcia

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must not be taking: Opioids, Mefloquine, Antipsychotics

Disqualifiers: Dialysis, Transplanted organs, Brain metastases, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 7 weeks

228 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region

Are You a Good Fit for This Trial?

This trial is for adults with squamous cell carcinoma of the head and neck who haven't had prior treatments for this cancer, can swallow pills, and have no severe kidney issues or organ transplants. It's not for those with known allergies to gabapentin, previous surgery or radiation in the area (except thyroid cancer treated with surgery and radioactive iodine), concurrent other cancer treatments, brain metastases, or plans for more cancer therapy post-trial.

Inclusion Criteria

Able to swallow capsules whole

No known hypersensitivity to gabapentin or its ingredients

Creatinine ≤ 1.5 x upper limit of normal (ULN)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high-dose gabapentin or placebo alongside standard chemoradiation therapy

7 weeks

Weekly visits for radiation treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Follow-up visits at 4 weeks, 3 months, and 6 months

Long-term Follow-up

Participants are monitored for long-term outcomes and adverse events

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Gabapentin

Trial Overview The HOPE trial is testing if high-dose gabapentin can reduce opioid use by preventing pain from mouth sores caused by chemoradiation in head and neck cancer patients. Participants will either receive gabapentin or a placebo alongside standard chemotherapy and radiation treatment.

How Is the Trial Designed?

Group I: Arm II (Gabapentin) Experimental Treatment 6 Interventions

Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.

Group II: Arm I (Placebo) Placebo Group 6 Interventions

Starting by radiation treatment 8, patients receive placebo PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+