Clinical trial · Interventional
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 Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Head and Neck Neoplasm | Malignant Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mucositis | — | UNRESOLVED | — |
| Radiation-Induced Disorder | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Intervention | Other | — | UNRESOLVED |
| Fentanyl | Drug | — | UNRESOLVED |
| Gabapentin | Drug | — | UNRESOLVED |
| Hydrocodone/Acetaminophen | Drug | — | UNRESOLVED |
| Ibuprofen | Drug | Ibuprofen | ALIAS |
| Magic Mouthwash | Drug | — | UNRESOLVED |
| Oxycodone/Acetaminophen | Drug | — | UNRESOLVED |
| Pain Therapy | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I Standard of Care
- description
- Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.
- interventionNames
- Other: Educational Intervention
- Other: Pain Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Oxycodone/Acetaminophen
- Drug: Hydrocodone/Acetaminophen
- Drug: Fentanyl
- Drug: Ibuprofen
- Drug: Magic Mouthwash
- type
- EXPERIMENTAL
- label
- Arm II Standard of Care Plus Gabapentin
- description
- Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available