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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
ClinicalTrials.gov ID: NCT06992427
What this study is testing
What is Gabapentin?
Gabapentin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma.
Also referred to as Gralise, Neurontin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Surprise, Arizona, United States
- Tempe, Arizona, United States
- Bakersfield, California, United States
- Dublin, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- San Leandro, California, United States
- San Rafael, California, United States
- Santa Clara, California, United States
+ 145 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Surprise, Arizona, United States; Tempe, Arizona, United States and 159 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.