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Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy
Sponsor: Nantes University Hospital
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
Conditions
Interventions
Phycocare
Phycocare every day during 9 months (except days of chemotherapy: no Phycocare)
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