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NCT05025826
NA

Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%. Clinically, CIPN is a mostly sensory neuropathy that may be accompanied by motor and autonomic changes of varying intensity and duration. Due to its high prevalence among cancer patients, CIPN constitutes a major problem for both cancer patients and survivors as well as for their health care providers, especially because, at the moment, there is no single effective method of preventing CIPN; moreover, the possibilities of treating this syndrome are very limited. The phycocyanin (PC), a biliprotein pigment and an important constituent of the blue-green alga Spirulina platensis, has been reported to possess significant antioxidant and radical-scavenging properties, offering protection against oxidative stress. Study hypothesis is that phycocyanin may give protection against oxaliplatin-induced neuropathy in the treatment of gastro intestinal cancers including oesogastric, colo-rectal and pancreatic cancers. This trial will be a randomised placebo-controlled study.

Official title: Randomized, Double-blind, Multicenter Placebo-controlled Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2022-04-01

Completion Date

2026-03

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

OTHER

Phycocare

Phycocare every day during 9 months (except days of chemotherapy: no Phycocare)

OTHER

Placebo

Placebo every day during 9 months (except days of chemotherapy = no Placebo)

Locations (8)

Clermont-Ferrand UH

Clermont-Ferrand, France, France

Centre Hospitalier de Cholet

Cholet, France

Chd La Roche Sur Yon

La Roche-sur-Yon, France

Hôpital le Confluent

Nantes, France

Nantes Uh

Nantes, France

Saint Gregoire Clinique

Rennes, France

Mutaliste Clinic Saint Nazaire

Saint-Nazaire, France

Foch Suresnes Hosptial

Suresnes, France