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NCT06992427 · ClinicalTrials.gov registry record · Phase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
A Phase 3 study of Head and Neck Squamous Cell Carcinoma and Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
- 20
- Study locations
NCT06992427: Recruiting Phase 3 study of Head and Neck Squamous Cell Carcinoma and Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
NCT06992427 is a Phase 3 study of Head and Neck Squamous Cell Carcinoma and Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 228 participants, above the 115-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06992427, a Phase 3 study of Head and Neck Squamous Cell Carcinoma and Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- RADIATION Radiation Therapy
- DRUG Gabapentin
- DRUG Chemotheraphy
- DRUG Analgesic Agent
Study Locations (20)
California
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente- Modesto MOB II - Modesto
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente Downtown Commons - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
Arizona
- Arizona Center for Cancer Care - Gilbert - Gilbert
- Arizona Center for Cancer Care-Peoria - Peoria
- Arizona Center for Cancer Care - Biltmore - Phoenix
- Arizona Center for Cancer Care - Phoenix - Phoenix
- Arizona Center for Cancer Care - Osborn - Scottsdale
- Arizona Center for Cancer Care - Scottsdale - Scottsdale
- Arizona Center for Cancer Care-Surprise - Surprise
- Arizona Center for Cancer Care - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2031-04-15 |
| Phase | Phase 3 |
What NCT06992427 shows while recruiting
NCT06992427 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (98% higher).
The record links to 5 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT06992427 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06992427 about?
NCT06992427 is a clinical study titled "High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer". 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 trea...
What is the current status of trial NCT06992427?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2025-06-05. Estimated completion is 2031-04-15.
What conditions does trial NCT06992427 study?
This clinical trial studies the following conditions: 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.
What interventions are being tested in trial NCT06992427?
The interventions under investigation include: Placebo (DRUG), Radiation Therapy (RADIATION), Gabapentin (DRUG), Chemotheraphy (DRUG), Analgesic Agent (DRUG).
Who is sponsoring clinical trial NCT06992427?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06992427 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06992427's enrollment target sits among peer trials
228 14th of 124 higher than 111 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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