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This study aimed to evaluate the safety and feasibility of combining gabapentin and intranasal ketamine to manage pain in head and neck cancer patients undergoing radiotherapy.

May 29, 2026

Gabapentin plus intranasal ketamine for the prevention and treatment of pain in patients undergoing radiotherapy for head and neck cancer: Phase II trial results.

Key Points

This study aimed to evaluate the safety and feasibility of combining gabapentin and intranasal ketamine to manage pain in head and neck cancer patients undergoing radiotherapy.
Phase II trial involving locally advanced head and neck cancer patients receiving gabapentin and intranasal ketamine during radiotherapy.
Gabapentin administered at 100 mg TID on Day 1, increased to 300 mg TID by Day 8; intranasal ketamine added on Day 15 at 30 mg TID.
Toxicity assessed via CTCAE 5.0, feasibility determined through pill counts and patient logs.
16% of patients experienced grade 2+ toxicity, primarily related to ketamine, with 13% discontinuing due to adverse effects.
Median pain score peaked at 4.3/10 during treatment, decreasing to 1.7/10 at 2 months post-treatment, with 18% of patients requiring no opioids.
91% of patients missed <5% of gabapentin doses and 78% missed <5% of ketamine doses, indicating high treatment adherence.

Abstract

12135 Background: Prophylactic gabapentin decreases pain, opioid use, and weight loss in head and neck (HNC) patients treated with chemoradiotherapy. Nonetheless, significant symptom burden remains. Ketamine is an NMDA receptor antagonist which has neuromodulator and anti-inflammatory properties. We undertook a phase I/II study to explore safety, feasibility, and obtain preliminary efficacy data pertaining to the combination of ketamine and gabapentin in HNC patients undergoing radiation +/- chemotherapy. Results of the phase I study were previously reported. Herein we report preliminary results of the phase II portion of the study. Primary outcomes were toxicity and feasibility; secondary outcomes were symptom burden. Methods: Eligibility: locally advanced HNC patients planned for primary or adjuvant radiotherapy +/- chemotherapy. Treatment: Day 1: gabapentin 100 mg PO TID; Day 8: increase gabapentin to 300 mg PO TID; Day 15: continue gabapentin and start intranasal ketamine 30 mg TID. Dose modifications were allowed for both agents. Toxicity: assessed using CTCAE 5.0. Feasibility: data capture by pill counts and patient medication logs. Efficacy: patient reported outcomes measures completed at baseline, weekly during radiation and 1-, 2-, and 3-months post-radiation. Results: Patient characteristics: median age 60 yrs, 85% males, 67% p16-positive, 21 post-operative. Toxicity: Of 45 patients who completed treatment, 7 patients (16%) experienced a grade 2+ toxicity (5 were probably related to ketamine). Four patients required ketamine dose de-escalation due to dizziness. Six patients (13%) eventually discontinued ketamine due to toxicity. Feasibility: 41 (91%) patients missed 90 days. Conclusions: The combination of gabapentin and ketamine was safe and feasible. Preliminary data indicates the majority of patients experienced low to moderate levels of pain with minimal use of opioids. Larger, randomized studies are warranted to confirm the benefit of the combination of gabapentin and ketamine. Clinical trial information: NCT05156060 .

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Gabapentin plus intranasal ketamine for the prevention and treatment of pain in patients undergoing radiotherapy for head and neck cancer: Phase II trial results.

Key Points

Abstract

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