Gabapentin for Mouth Pain from Head and Neck Cancer Treatment

High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer

Recruiting Phase 3 Interventional Study
Head and Neck Squamous Cell Carcinoma Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
228 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Who this trial is looking for

This trial is looking for people with head and neck cancer who are receiving treatment to see if gabapentin can help reduce pain from mouth sores and decrease the need for opioid medications. Participants will take gabapentin or a placebo during their treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with squamous cell carcinoma of the head and neck.
  • I am starting treatment with chemotherapy and radiation.
  • I am able to swallow capsules whole.
  • I am at least 18 years old.
  • I have a good performance status (ECOG ≤ 2).
  • I have normal kidney function (creatinine ≤ 1.5 times the upper limit of normal).
  • I am not pregnant or nursing.
  • I do not have any known allergies to gabapentin.

You may not be able to join if

  • I have had surgery or radiation for head and neck cancer in the past.
  • I have any known brain metastases.
  • I do not use any opioids or prescription pain medications for chronic pain.
  • I have uncontrolled health issues such as active infections or heart problems.
  • I have a diagnosis of sleep apnea.
  • I am currently taking mefloquine.
  • I have a history of psychotic psychiatric illness.
  • I have participated in another study involving pain control agents in the last 30 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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, wor…
Trial Locations
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Eligibility Criteria
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 swall…
Contacts

Nancy Garcia

773-702-9171

cancercontrolprotocols@alliancenctn.org

CONTACT