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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 is a Phase 3 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 79 participants.

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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.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • OTHER Educational Intervention
  • DRUG Gabapentin
  • OTHER Pain Therapy

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2015-07
Est. Completion 2020-01
Phase Phase 3

Sponsor

Vanderbilt-Ingram Cancer Center

189 total trials

What the Registry Record Tells You About NCT02480114

The ClinicalTrials.gov registry entry for NCT02480114 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT02480114 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.