RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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

Official Title

High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial

Quick Facts

Study Start:2025-06-05
Study Completion:2031-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06992427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic documentation of disease: Squamous cell carcinoma of the head and neck region.
  2. * No prior treatment for head and neck cancer
  3. * Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks \[q 3 week\])
  4. * Able to swallow capsules whole
  5. * No known hypersensitivity to gabapentin or its ingredients
  6. * No patients on dialysis or with transplanted organs
  7. * 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
  8. * No planned surgery or chemotherapy or immunotherapy following 7 weeks of standard chemoradiation treatment
  9. * No known brain metastases
  10. * No nonprescribed use of any opioids (including heroin) within 6 months prior to registration
  11. * 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
  12. * No current treatment with mefloquine
  13. * Age ≥ 18 years
  14. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  15. * Creatinine ≤ 1.5 x upper limit of normal (ULN)
  16. * 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
  17. * Not taking medications for a psychotic psychiatric illness
  18. * No existing diagnosis of sleep apnea
  19. * No acute narrow-angle glaucoma
  20. * 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
  21. * No investigational agent within 30 days prior to registration
  22. * No enrollment on other studies of systemic pain control agents
  23. * Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish
  24. * Patients with impaired decision making are not eligible for study
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nancy Garcia
CONTACT
773-702-9171
cancercontrolprotocols@alliancenctn.org

Study Locations (Sites)

Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
United States
Mercy Hospital
Cedar Rapids, Iowa, 52403
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-05
Study Completion Date2031-04-15

Study Record Updates

Study Start Date2025-06-05
Study Completion Date2031-04-15

Terms related to this study

Additional Relevant MeSH Terms

  • 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