Neoplasms

Digestive System Diseases

All Conditions

Nervous System Diseases

Substance Related Disorders

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Neurotoxicity Syndromes

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Syndrome

Gastrointestinal Diseases

Poisoning

Chemically-Induced Disorders

Intestinal Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

PHYCOCARE during 12 cycles of 14 days from day -3 before oxaliplatin based chemotherapy until cycle 3 months after the last dose of oxaliplatin (18 cycles, about 9 months) From D-3 to D14 before cycle 1 chemotherapy: patient will take Phycocare From D1 to D14 of cycle 2 chemotherapy and further chemotherapy cycles : patient will take Phycocare On days of chemotherapy the patient does not take Phycocare

Placebo during 12 cycles of 13 days from day -3 before cycle 1 of oxaliplatin based chemotherapy until 3 months after the last dose of oxaliplatin (9 months).

From D-3 to D13 before cycle 1 chemotherapy: patient will take Placebo From D1 to D13 of cycle 2 chemotherapy and further chemotherapy cycles : patient will take Placebo.

On days of chemotherapy the patient does not take Placebo

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

Phycocare

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

Placebo

Yann TOUCHEFEU, Professor

Victor SIMMET, MD

Caroline PETORIN, MD

Didier PEZET, PH

Paul GIROT, MD

Hélène CASTANIE, MD

Adeline LE CARRET-MORVAN

Clément PERRET, MD

Catherine Ligeza- Poisson, MD

Jaafar BENNOUNA, MD-PHD

Asmahane Benmaziane, MD-PHD

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.

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.

The placebo will match as much as possible all the characteristics of the Phycocare®

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

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

neurotoxicity according to NCI (National Cancer Institute) criteria in both arms

Delay of definitive interruption or decrease of oxaliplatin treatment

Neurological AE at following hospital visit : baseline, M4 and M9/end of study visit

QLQ C30 - score questions 1 to 28: score frame \[30-114\] . 30= good quality of life questions 29 and 30 : score frame \[2-14\] . 2 = bad quality of lifre

ElectroNeuroMyography (ENMG) and neurology questionnaire ONLS (overall neuropathy limitations scale)

ONLS score:

* sub-score upper limbs : \[0-5\] . 5= worst neuropathic injury
* sub score lower limbs \[0-7\]: 7= worst neuropathic injury
* total score = upper limbs score + lower limbs score \[0-12\] ; 0= no injury; 12= maximal incapacity

Spots Global Cancer Trial Database for phycocare

Every month we try and update this database with for phycocare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for phycocare

Every month we try and update this database with for phycocare cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for phycocare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.