High-dose gabapentin versus placebo to prevent opioid use for mouth pain during chemoradiation for head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, phase III trial comparing prophylactic high-dose gabapentin (titrated to 3600 mg per day) versus placebo in patients receiving cisplatin-based chemoradiation for squamous cell carcinoma of the head and neck. Participants are randomized to receive gabapentin or matching placebo while undergoing standard radiation and chemotherapy, with opioid use, time to first opioid, and patient-reported pain tracked prospectively. The primary outcome is the proportion of patients who do not require opioid medications during treatment; secondary outcomes include time to first opioid use and changes in pain scores through four weeks after treatment. Exploratory analyses examine duration of opioid use and quality-of-life and symptom trajectories over months following therapy.

Why it matters

Who can join: the full rules

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:

\-

Where it's running

• Arizona Center for Cancer Care - Gilbert
  Gilbert, Arizona, United States Recruiting
• Arizona Center for Cancer Care-Peoria
  Peoria, Arizona, United States Recruiting
• Arizona Center for Cancer Care - Biltmore
  Phoenix, Arizona, United States Recruiting
• Arizona Center for Cancer Care - Phoenix
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic Hospital in Arizona
  Phoenix, Arizona, United States Recruiting
• Arizona Center for Cancer Care - Osborn
  Scottsdale, Arizona, United States Recruiting

+166 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Nancy Garcia
• Email: cancercontrolprotocols@alliancenctn.org
• Phone: 773-702-9171

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding BMX-001, a drug that protects normal tissue from radiation damage, to standard chemoradiation for head and neck cancer

  This trial tests whether giving BMX-001 along with usual mouth-care reduces severe mouth sores in people getting cisplatin-based chemoradiation for HPV-related and other head and neck cancers.

  Recruiting at 146 sites Phase 2 NRG Oncology · Gilbert, Arizona and 152 other locations · NCT06532279

• Camonsertib added to precise radiation therapy for recurrent head and neck cancer

  This early-phase study tests whether the cancer drug camonsertib, given with targeted SBRT radiation, is safe and tolerable for people with recurrent or unresectable head and neck squamous cell carcinoma.

  Recruiting at 4 sites Phase 1 National Cancer Institute (NCI) · Duarte, California and 3 other locations · NCT07156227

• Personalized vaccine combined with pembrolizumab for advanced solid tumors

  This study is testing a new personalized cancer vaccine combined with pembrolizumab to see if it helps people with advanced solid tumors fight their cancer better.

  Recruiting Phase 1/2 Mayo Clinic · Jacksonville, Florida · NCT05269381

• Neoadjuvant therapy with nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin for locally advanced head and neck cancer

  This study tests a pre-surgery treatment combining targeted therapy, immunotherapy, and chemotherapy to see if it helps patients with locally advanced, resectable head and neck squamous cell carcinoma.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Hebei, Hebei · NCT07906587

• ICG with near-infrared imaging to visualize head and neck cancer during surgery

  This study tests whether first-window indocyanine green fluorescence seen during surgery matches the cancer extent seen on pathology in patients with head and neck squamous cell carcinoma.

  Recruiting Phase 2 Washington University School of Medicine · St Louis, Missouri · NCT07825597

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.