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NCT02480114 · ClinicalTrials.gov registry record · Phase 3
Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy
A Phase 3 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 79
- Enrollment target
NCT02480114: Completed Phase 3 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT02480114 is a Phase 3 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 79 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02480114, a Phase 3 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 79 participants
- Enrollment target
Study Summary
This randomized phase III trial studies how well gabapentin plus standard of care work compares to standard of care without Gabapentin in preventing inflammation of the mucous membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and neck may cause a burn involving the inside of the mouth, throat, and nasal passages, resulting in pain. Gabapentin may help prevent (or minimize) pain associated with radiation-induced mucositis in patients with head and neck cancer.
Primary Outcome
The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Educational Intervention
- DRUG Gabapentin
- OTHER Pain Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2015-07 |
| Est. Completion | 2020-01 |
| Phase | Phase 3 |
What the finished NCT02480114 record still lists
NCT02480114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02480114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02480114 about?
NCT02480114 is a clinical study titled "Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy". This randomized phase III trial studies how well gabapentin plus standard of care work compares to standard of care without Gabapentin in preventing inflammation of the mucous membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing primary or subsequent (adjuvant...
What is the current status of trial NCT02480114?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2015-07. Estimated completion is 2020-01.
What interventions are being tested in trial NCT02480114?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Educational Intervention (OTHER), Gabapentin (DRUG), Pain Therapy (OTHER).
Who is sponsoring clinical trial NCT02480114?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02480114's enrollment target sits among peer trials
79 1768th of 2000 higher than 232 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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