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. 2023 Jan 20;24(1):50.
doi: 10.1186/s13063-023-07071-z.

PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy

Christele Le Gouill-Jaijarat  1 , Yann Péréon  2 , Maxime Leroy  3 , Olivier Lépine  4 , Aymeric Loloum  4 , Claire Peluchon  1   5 , Christelle Volteau  3 , Anne-Sophie Martineau  3 , Simon Korner  3 , Caroline Perrault  3 , Asmahane Benmaziane  6 , Paul Girot  7 , Caroline Petorin  8 , Clément Perret  9 , Catherine Ligeza-Poisson  10 , Didier Mayeur  11 , Laurent Flet  12 , Anne Chiffoleau  3 , Alexandra Poinas  13 , Jaafar Bennouna  6
Affiliations

PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy

Christele Le Gouill-Jaijarat et al. Trials. .

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse effects of antineoplastic agents, ranging in prevalence from 19% to over 85%. Clinically, CIPN is a predominantly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. The high prevalence of CIPN among cancer patients makes it a major problem for both patients and survivors, as well as for their health care providers, especially because there is currently no single effective method of preventing CIPN; moreover, the options for treating this syndrome are very limited. Phycocyanin, a biliprotein pigment and an important constituent of the blue-green algae Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress, which is one of the hypothetic mechanisms, between others, of CIPN occurrence.

Methods: Our hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastrointestinal cancers. Our trial will be a randomized double-blind placebo-controlled study with 110 randomized patients suffering from metastatic gastrointestinal adenocarcinoma including esogastric, colorectal, and pancreatic cancers. Patients are being followed up in the gastroenterology or oncology departments of seven French hospitals.

Discussion: Due to the neuropathy, patients need to avoid injury by paying careful attention to home safety; patients' physicians often prescribe over-the-counter pain medications. If validated, our hypothesis should help to limit neurotoxicity without the need to discontinue chemotherapy.

Trial registration: ClinicalTrials.gov NCT05025826. First published on August 27, 2021.

Keywords: Adverse drug reaction; Chemotherapy-induced peripheral neuropathy; Neurotoxicity; Oxaliplatin; Phycocyanin; Prophylaxis; Randomized controlled trial; Sensory neuropathy; Spirulina extract.

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Conflict of interest statement

There are no financial or competing interests to be declared for the investigators.

Figures

Fig. 1
Fig. 1
Study diagram
Fig. 2
Fig. 2
Schedule of trial treatment in chemotherapy cycles
See this image and copyright information in PMC

References

    1. Arnold M, Abnet CC, Neale RE, Vignat J, Giovannucci EL, McGlynn KA, et al. Global burden of 5 major types of gastrointestinal cancer. Gastroenterology. 2020;159:335–349.e15. doi: 10.1053/j.gastro.2020.02.068. - DOI - PMC - PubMed
    1. Marin JJG, Perez-Silva L, Macias RIR, Asensio M, Peleteiro-Vigil A, Sanchez-Martin A, et al. Molecular bases of mechanisms accounting for drug resistance in gastric adenocarcinoma. Cancers (Basel) 2020;12(8):2116. doi: 10.3390/cancers12082116. - DOI - PMC - PubMed
    1. Argyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Crit Rev Oncol Hematol. 2012;82:51–77. doi: 10.1016/j.critrevonc.2011.04.012. - DOI - PubMed
    1. Ma Y-M, Ibeanu G, Wang L-Y, Zhang J-Z, Chang Y, Dong J-D, et al. Selenium suppresses glutamate-induced cell death and prevents mitochondrial morphological dynamic alterations in hippocampal HT22 neuronal cells. BMC Neurosci. 2017;18 Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5244737/. Cited 2020 Oct 26. - PMC - PubMed
    1. Oun R, Moussa YE, Wheate NJ. The side effects of platinum-based chemotherapy drugs: a review for chemists. Dalton Trans. 2018;47:6645–6653. doi: 10.1039/C8DT00838H. - DOI - PubMed

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