Gabapentin for Pain in Head and Neck Cancer

(HOPE Trial)

Recruiting at 109 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 trial tests whether gabapentin, a medication often used for nerve pain, can reduce mouth sore pain in head and neck cancer patients undergoing chemotherapy and radiation. This may lower the need for opiate pain medications. Mouth sores, a common side effect of this cancer treatment, cause severe pain and other health issues. Gabapentin could provide pain relief without the side effects associated with opioids. Patients with untreated squamous cell carcinoma of the head and neck who can swallow pills may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you do not take prescribed medications for chronic or long-term pain, and you must stop any acute post-biopsy medications 3 days before joining. You also cannot be on opioids, mefloquine, or medications for psychotic psychiatric illnesses.

Is there any evidence suggesting that gabapentin is likely to be safe for humans?

Research has shown that gabapentin effectively manages pain from radiation treatments and is well-tolerated. Studies have found that gabapentin can reduce pain from oral mucositis, painful mouth sores, in patients with head and neck cancer. This is crucial because oral mucositis often leads to increased use of strong pain medications like opioids, which have many side effects.

In past studies, patients taking gabapentin reported better pain relief during cancer treatment. Gabapentin is already approved for other uses, so its safety profile is well-known. While all medications can have side effects, gabapentin is generally considered safe when used as directed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Gabapentin is unique for treating pain in head and neck cancer because it targets nerve-related pain, which is different from the standard of care options like opioids and non-steroidal anti-inflammatory drugs (NSAIDs) that primarily focus on general pain relief. Gabapentin works by calming down overactive nerves, which can be particularly beneficial for managing the specific type of pain associated with cancer treatments. Researchers are excited about gabapentin because it may offer an effective pain management option with potentially fewer side effects compared to traditional pain medications, providing a better quality of life for patients.

What evidence suggests that gabapentin might be an effective treatment for oral mucositis pain in head and neck cancer?

Research has shown that gabapentin, which participants in this trial may receive, can help manage pain from mouth sores in individuals undergoing treatment for head and neck cancer. Studies have found that gabapentin reduces pain from these sores and may decrease the need for opiate pain medications, which often cause side effects like constipation and tiredness. Additionally, gabapentin is effective and well-tolerated for easing pain from radiation treatment. Overall, evidence suggests gabapentin could be a helpful option for managing this type of pain. ^{3 6 7 8 9}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40019561/

Efficacy of prophylactic gabapentin in managing oral ... Conclusion: Overall, there was a positive trend in reducing oral mucositis-related pain in patients undergoing chemoradiation of the head and ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-00501

High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to ... Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06992427

High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to ... This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2792383

Association of Gabapentin Use With Pain Control and ... This comparative-effectiveness study uses data from 2 clinical trials to evaluate whether the use of gabapentin for pain management is ...

5. ascopubs.org ascopubs.org/doi/10.1200/jco.2007.25.18_suppl.16513

Gabapentin for the treatment of pain related to radiation ... Conclusions: Gabapentin is effective and well-tolerated for the treatment of mucositis-induced pain related to radiation treatment in patients with head and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10023599/

Prophylactic gabapentin during head and neck cancer therapy The current state of evidence rests on the fact that there are two clinical trials demonstrating improved pain with gabapentin during HNC ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02480114

Study Details | NCT02480114 | Gabapentin Compared to ... Gabapentin may help prevent (or minimize) pain associated with radiation-induced mucositis in patients with head and neck cancer. Detailed Description.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2810484

Severe Oral Mucositis After IMRT for Head and Neck Cancer The sequelae of OM have been shown to increase opioid use, weight loss, feeding tube placement, and hospitalization among patients with HNC.

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.25274

Gabapentin for the treatment of pain syndrome related to ... The results of the current study support the use of gabapentin as both an effective and well-tolerated treatment for pain related to radiation-induced ...