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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
110
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
Demonstrate a 50% decrease of the grade> or = 2 neurotoxicity at 4 months after oxaliplatin-based chemotherapy start in the PHYCOCARE arm
neurotoxicity according to NCI (National Cancer Institute) criteria in both arms
Time frame: 4 months after oxaliplatin-based chemotherapy start
Comparison between the two arms of percentage of patients who stopped oxaliplatin for neurological toxicity
Delay of definitive interruption or decrease of oxaliplatin treatment
Time frame: last day of chemotherapy
Comparison between the two arms of percentage of patients with oxaliplatin dose decrease
Dose intensity of oxaliplatin
Time frame: last day of chemotherapy
Comparison between the two arms of Neurological toxicities according to the Common Terminology Criteria for adverse Event (CTCAE) v5.0
Neurological AE at following hospital visit : baseline, M4 and M9/end of study visit
Time frame: end of study visit (an average of 9 months after cycle 1 day1)
Comparison between the two arms of Overall Toxicity (including hematological toxicity, gastro-intestinal toxicity, etc…)
Adverse events grade 1 to 4
Time frame: end of study visit (an average of 9 months after cycle 1 day1)
Comparison between the two arms of Patient 's Quality of Life according with EORTC-QLQ-C30
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
Time frame: end of study visit (an average of 9 months after cycle 1 day1)
Comparison between the two arms of Neurological toxicities
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
Time frame: end of study visit (an average of 9 months after cycle 1 day1)
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