NCT06992427 · Alliance for Clinical Trials in Oncology
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
(HOPE)
What this study is about
This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (taken by mouth mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region.
View original scientific description
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.
Interventions
DRUG
Gabapentin
Given PO
DRUG
Placebo
Given PO
DRUG
Chemotheraphy
Receive standard of care chemotherapy
RADIATION
Radiation Therapy
Undergo standard of care radiation
DRUG
Analgesic Agent
Receive standard of care pain medication
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
Need to use opioids during chemoradiation therapy (CRT)
Time frame: Up to 7 weeks
Will be tested using a two-sample test of proportions. Will report the proportion of patients not using opioids within the 7 weeks of CRT in the two arms and the 95% confidence interval (CI) of the difference in the proportions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 lon
Where
- Gilbert, Arizona
- Peoria, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Surprise, Arizona
- Tempe, Arizona
- Bakersfield, California
- Dublin, California
- Fremont, California
- Fresno, California
- Los Angeles, California
- Modesto, California
And 153 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations