Clinical trial · Interventional
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 | Head and Neck Cutaneous Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 | Head and Neck Cutaneous Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 | Head and Neck Cutaneous Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 | Head and Neck Cutaneous Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Analgesic Agent | Drug | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Chemotheraphy | Drug | — | UNRESOLVED |
| Gabapentin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm I (Placebo)
- description
- 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.
- interventionNames
- Drug: Placebo
- Drug: Chemotheraphy
- Radiation: Radiation Therapy
- Drug: Analgesic Agent
- Procedure: Biospecimen Collection
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Arm II (Gabapentin)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic documentation of disease: Squamous cell carcinoma of the head and neck region. \* Stage: I-IV * No prior treatment for head and neck cancer * Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks \[q 3 week\]) * Able to swallow capsules whole * No known hypersensitivity to gabapentin or its ingredients * No patients on dialysis or with transplanted organs * No prior surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer. Patients with a history of surgery and radioactive iodine for the treatment of thyroid cancer are eligible. Concurrent cancer therapy for other cancers is not allowed * No planned surgery or chemotherapy or immunotherapy following 7 weeks of standard chemoradiation treatment * No known brain metastases * No nonprescribed use of any opioids (including heroin) within 6 months prior to registration * No prescribed medications for chronic and/or long-term pain and/or neuropathy, including patients under treatment of a pain specialist or substance abuse programs. Acute post-biopsy medications are allowed if the patient has discontinued them 3 days prior to study registration * No current treatment with mefloquine * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Creatinine ≤ 1.5 x upper limit of normal (ULN) * Not pregnant and not nursing, because this study involves both radiation and chemotherapy. In addition, the genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential, a negative pregnancy test done \< 7 days prior to registration is required. Women must agree to using contraception for the duration of receiving study drugs and for 6 months after completing chemoradiation * Not taking medications for a psychotic psychiatric illness * No existing diagnosis of sleep apnea * No acute narrow-angle glaucoma * No 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 * No investigational agent within 30 days prior to registration * No enrollment on other studies of systemic pain control agents * Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish * Patients with impaired decision making are not eligible for study Exclusion Criteria: \-
References
Publications (0)
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