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Randomized Controlled Trial
. 2020 Apr 1;126(7):1480-1491.
doi: 10.1002/cncr.32676. Epub 2019 Dec 23.

A single-institution, randomized, pilot study evaluating the efficacy of gabapentin and methadone for patients undergoing chemoradiation for head and neck squamous cell cancer

Gregory M Hermann  1 , Austin J Iovoli  2 , Alexis J Platek  2 , Chong Wang  3 , Austin Miller  3 , Kristopher Attwood  3 , Daniel J Bourgeois  1   4 , Anurag K Singh  1
Affiliations
Randomized Controlled Trial

A single-institution, randomized, pilot study evaluating the efficacy of gabapentin and methadone for patients undergoing chemoradiation for head and neck squamous cell cancer

Gregory M Hermann et al. Cancer. .

Erratum in

Abstract

Background: The objective of the current study was to compare the safety and efficacy between 2 analgesic regimens for patients with head and neck cancer (HNC) undergoing definitive chemoradiation (CRT).

Methods: The current study was a prospective, single-institution, 2-arm, randomized pilot study. Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT were randomized to either arm 1, which entailed high-dose gabapentin (2700 mg daily) with the institutional standard of care (hydrocodone and/or acetaminophen progressing to fentanyl as needed), or arm 2, which comprised low-dose gabapentin (900 mg daily) with methadone. The primary endpoints were safety and toxicity. Secondary endpoints were pain, opioid requirement, and quality of life (QOL). Differences between the treatment arms at multiple time points were compared using a generalized linear mixed regression model with Sidak correction.

Results: A total of 60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017. There was no difference between the treatment arms with regard to adverse events or serious adverse events. Pain was not found to be different between the treatment arms. More patients in arm 1 did not require an opioid during treatment (42% vs 7%; P = .002). Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (P = .05), physical functioning (P = .04), role functioning (P = .01), and social functioning (P = .01).

Conclusions: High-dose prophylactic gabapentin increased the percentage of patients who required no opioid during treatment. Methadone may improve QOL compared with a regimen of short-acting opioids and fentanyl. However, pain was found to significantly worsen throughout treatment regardless of treatment arm, necessitating further studies to identify a more optimal regimen.

Keywords: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; Oral Mucositis Weekly Questionnaire adapted for head and neck cancer (OMWQ-HN); oral mucositis; patient-report outcomes; quality of life; version 3.0 (EORTC QLQ-C30).

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Conflict of interest statement

Conflict of interest

All authors declare that they have no competing interests.

Figures

Figure 1.
Figure 1.
Consolidated Standard of Reporting Trials (CONSORT) trial diagram. Arm 1: High dose prophylactic gabapentin (2700mg) with hydrocodone/acetaminophen escalating to fentanyl; Arm 2: Low dose gabapentin (900mg) with methadone.
Figure 2.
Figure 2.
EORTC QLQ-C30 scores by arm. (A) Global health scale, (B) Physical functioning, (C) Role functioning, (D) Emotional functioning, (E) Cognitive functioning, (F) Social functioning.
Figure 2.
Figure 2.
EORTC QLQ-C30 scores by arm. (A) Global health scale, (B) Physical functioning, (C) Role functioning, (D) Emotional functioning, (E) Cognitive functioning, (F) Social functioning.
Figure 2.
Figure 2.
EORTC QLQ-C30 scores by arm. (A) Global health scale, (B) Physical functioning, (C) Role functioning, (D) Emotional functioning, (E) Cognitive functioning, (F) Social functioning.
Figure 2.
Figure 2.
EORTC QLQ-C30 scores by arm. (A) Global health scale, (B) Physical functioning, (C) Role functioning, (D) Emotional functioning, (E) Cognitive functioning, (F) Social functioning.
Figure 2.
Figure 2.
EORTC QLQ-C30 scores by arm. (A) Global health scale, (B) Physical functioning, (C) Role functioning, (D) Emotional functioning, (E) Cognitive functioning, (F) Social functioning.
Figure 2.
Figure 2.
EORTC QLQ-C30 scores by arm. (A) Global health scale, (B) Physical functioning, (C) Role functioning, (D) Emotional functioning, (E) Cognitive functioning, (F) Social functioning.
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