Phase 3
N=79
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
Malignant Head and Neck Neoplasm · Mucositis · Radiation-Induced Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02480114 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS)) — 4.26; 3.68 score on a scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Educational Intervention (Other); Gabapentin (Drug); Pain Therapy (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Oxycodone/Acetaminophen (Drug); Hydrocodone/Acetaminophen (Drug); Fentanyl (Drug); Ibuprofen (Drug); Magic Mouthwash (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS)) |
4.26; 3.68 | 0.004 sig |
| SECONDARY Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0) |
0; 0 | 1 |
| SECONDARY Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form) |
1.91; 1.23 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically proven cancer of the head and neck cancer
- Stage 3 or 4
- Planned primary or adjuvant chemoradiation therapy
- Willing and able to provide informed consent
- English speaking
Exclusion Criteria
- Currently on gabapentin
- Prior non-tolerance of gabapentin
- History of seizure disorder
Data sourced from ClinicalTrials.gov (NCT02480114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.