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Spots Global Cancer Trial Database for Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy

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Trial Identification

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

Interventions

Phycocare
Placebo

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Yann TOUCHEFEU, Professor

Affiliation: NANTES UH

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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