Gabapentin for Pain in Head and Neck Cancer
(HOPE Trial)
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.12345Why 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.36789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either high-dose gabapentin or placebo alongside standard chemoradiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for long-term outcomes and adverse events
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?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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.
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.
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acsjournals.onlinelibrary.wiley.com
acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.25274Gabapentin 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 ...
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