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Current Oncology
Volume 18
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Current Oncology is published by MDPI from Volume 28 Issue 1 (2021). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Multimed Inc..
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Article

A Multicentre Open-Label Safety and Efficacy Study of Tetrodotoxin for Cancer Pain

by
Neil Hagen
1,2,*,
B. Lapointe
3,4,
M. Ong-Lam
5,
B. Dubuc
6,
D. Walde
7,
B. Gagnon
8,
R. Love
9,10,
R. Goel
11,
P. Hawley
12,
A. Ho Ngoc
13 and
P. du Souich
14
1
Tom Baker Cancer Clin, Calgary, AB T2N 4N2, Canada
2
Departments of Oncology, Clinical Neurosciences, and Medicine, University of Calgary, Calgary, AB, Canada
3
Departments of Oncology and Family Medicine, McGill University, Montreal, QC, Canada
4
Jewish General Hospital, Montreal, QC, Canada
5
St. Paul’s Hospital, Vancouver, BC, Canada
6
Pain Clinic, Centre hospitalier de l’Université de Montréal–Hôtel Dieu, Montreal, QC, Canada
7
Department of Oncology, Sault Area Hospital, Sault Ste. Marie, ON, Canada
8
Departments of Medicine and Oncology, McGill University, Montreal, QC, Canada
9
Palliative Care, Nanaimo Regional General Hospital, Nanaimo, BC, Canada
10
Department of Family Medicine, University of British Columbia, Nanaimo, BC, Canada
11
Department of Oncology, The Ottawa Hospital, Ottawa, ON, Canada
12
BC Cancer Agency, Vancouver, BC, Canada
13
WEX Pharmaceuticals, Vancouver, BC, Canada
14
Département de Pharmacologie, Faculté de Médecine, Université de Montréal, Montreal, QC, Canada
 
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*
Author to whom correspondence should be addressed.
Curr. Oncol. 2011, 18(3), 109-116; https://doi.org/10.3747/co.v18i3.732
Submission received: 4 May 2011 / Revised: 11 May 2011 / Accepted: 20 May 2011 / Published: 1 June 2011

Abstract

Background: Cancer pain is highly prevalent, and existing treatments are often insufficient to provide adequate relief. Objectives: We assessed the long-term safety and efficacy of subcutaneous tetrodotoxin treatment in reducing the intensity of chronic cancer-related pain. Methods: In this multicentre open-label longitudinal trial, 30 μg tetrodotoxin was administered subcutaneously twice daily for 4 days in a heterogeneous cohort of patients with persistent pain despite opioids and other analgesics. “Responder” was defined as a mean reduction of 30% or more in pain intensity from baseline; and “clinical responder” as some pain reduction, but less than 30%, plus agreement on the part of both the patient and the physician that a meaningful analgesic response to treatment had occurred. Results: Of 45 patients who entered the longitudinal trial, 41 had sufficient data for analysis. Of all 45 patients, 21 (47%) met the criteria for “responder” [16 patients (36%)] or “clinical responder” [5 patients (11%)]. Onset of pain relief was typically cumulative over days, and after administration ended, the analgesic effect subsided over the course of a few weeks. No evidence of loss of analgesic effect was observed during subsequent treatments (2526 patient–days in total and a maximum of 400 days in 1 patient). One patient withdrew from the study because of adverse events. Toxicity was usually mild (82%) or moderate (13%), and remained so through subsequent treatment cycles, with no evidence of cumulative toxicity or tolerance. Conclusions: Long-term treatment with tetrodotoxin is associated with acceptable toxicity and, in a substantial minority of patients, resulted in a sustained analgesic effect. Further study of tetrodotoxin for moderate-to-severe cancer pain is warranted.
Keywords: Clinical trial; cancer pain; analgesic; tetrodotoxin; long-term; safety; efficacy; open-label Clinical trial; cancer pain; analgesic; tetrodotoxin; long-term; safety; efficacy; open-label

Share and Cite

MDPI and ACS Style

Hagen, N.; Lapointe, B.; Ong-Lam, M.; Dubuc, B.; Walde, D.; Gagnon, B.; Love, R.; Goel, R.; Hawley, P.; Ngoc, A.H.; et al. A Multicentre Open-Label Safety and Efficacy Study of Tetrodotoxin for Cancer Pain. Curr. Oncol. 2011, 18, 109-116. https://doi.org/10.3747/co.v18i3.732

AMA Style

Hagen N, Lapointe B, Ong-Lam M, Dubuc B, Walde D, Gagnon B, Love R, Goel R, Hawley P, Ngoc AH, et al. A Multicentre Open-Label Safety and Efficacy Study of Tetrodotoxin for Cancer Pain. Current Oncology. 2011; 18(3):109-116. https://doi.org/10.3747/co.v18i3.732

Chicago/Turabian Style

Hagen, Neil, B. Lapointe, M. Ong-Lam, B. Dubuc, D. Walde, B. Gagnon, R. Love, R. Goel, P. Hawley, A. Ho Ngoc, and et al. 2011. "A Multicentre Open-Label Safety and Efficacy Study of Tetrodotoxin for Cancer Pain" Current Oncology 18, no. 3: 109-116. https://doi.org/10.3747/co.v18i3.732

APA Style

Hagen, N., Lapointe, B., Ong-Lam, M., Dubuc, B., Walde, D., Gagnon, B., Love, R., Goel, R., Hawley, P., Ngoc, A. H., & du Souich, P. (2011). A Multicentre Open-Label Safety and Efficacy Study of Tetrodotoxin for Cancer Pain. Current Oncology, 18(3), 109-116. https://doi.org/10.3747/co.v18i3.732

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