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Brief Title: Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy
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
Study ID: NCT05025826
Brief 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.
Detailed Description: The phycocyanin used in this protocol (Phycocare®) will be 5 times more concentrated than the Spirulysat (food supplement commercialized by Algosource). It will be administrated during Oxaliplatin based chemotherapy and 3 months after oxaliplatin stopped.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier de Cholet, Cholet, , France
Clermont-Ferrand UH, Clermont-Ferrand, , France
DIJON UH, Dijon, , 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
Name: Yann TOUCHEFEU, Professor
Affiliation: NANTES UH
Role: PRINCIPAL_INVESTIGATOR