Étude randomisée, en double aveugle, multicentrique, contrôlée par placebo, évaluant la neurotoxicité chez des patients atteints d’un cancer gastro-intestinal métastatique prenant du phycocare ou un placebo pendant une chimiothérapie* à base d'oxaliplatine

Essai clinique

Type : Académique
Statut : Ouvert
Phase : Étude observationnelle
Étape du traitement : Stade métastatique 1er ligne
Date d'ouverture : 01/04/2022
Date clôture : 31/03/2025
Promoteur : Nantes University Hospital
Progression du cancer: Loco-régional et à distance
Résumé :

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.

Domaines/spécialités :
  • Cancers digestifs
    • Œsophage
    • Estomac
    • Colon
    • Rectum
    • Pancréas
Pathologies :
  • Tumeur maligne de l'oesophage - Cim10 : C15
  • Tumeur maligne de l'estomac - Cim10 : C16
  • Tumeur maligne du côlon - Cim10 : C18
  • Tumeur maligne du rectum - Cim10 : C20
  • Tumeur maligne du pancréas - Cim10 : C25
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :
  • Male or female with the age > or = to 18 years old.
  • Negative pregnancy test for women with child-bearing potential if applicable (without hysterectomy for example)
  • Information given to the patient who must have signed informed consent
  • Patient with Histologically or cytologically proven gastro intestinal cancer including oesogastric, colo-rectal and pancreatic cancers and planned to be treated with oxaliplatin
  • Patient with metastatic disease not previously treated
  • Patient willing not to take any plant-based therapy during the study (including phytotherapy and gemmotherapy)
  • Previous radiotherapy is authorized if discontinued ≥15 days prior to randomization
  • Sites of disease evaluated within 42 days prior C1 day 1 of chemotherapy with thoracic-abdominal-pelvic CT scan (or abdominal-pelvic MRI and chest X-ray)
  • Patient with ECOG Performance status 0 or 1
  • Patients with a Life expectancy ≥12 weeks
  • Laboratory results:

Hematologic function:

polynuclear neutrophils ≥ 1.5.109/L platelets ≥100.109/L haemoglobin ≥9 g/dL

Hepatic function:

transaminases ≤2.5 times upper limit of normal (ULN) (≤5 ULN in case of hepatic metastases), alkaline phosphatases ≤2.5 x ULN (≤5 ULN in case of hepatic metastases), total bilirubin ≤1.5 x ULN

Renal function:

creatinemia clearance >50 ml/min (Cockcroft and Gault)

- Patient with Public Health insurance coverage

Critères d’exclusion :
  • Patients with phenylketonuria
  • Patients with known meningeal or brain metastases
  • Patient previously treated for their metastatic cancer
  • Patient previously treated with oxaliplatin
  • Patient with specific contraindication or known hypersensitivity to spirulina
  • Patient with specific contraindication or known hypersensitivity to oxaliplatin.
  • If Patient is treated with a monoclonal antibody combined to chemotherapy (bevacizumab or cetuximab or panitumumab), known allergy or hypersensitivity to antibodies or any preservatives has to be excluded
  • Patient with clinically significant coronaries affection or myocardial infarction within 6 months prior to randomization.
  • Patient with peripheral neuropathy >1 (CTCAE scale version 5.0).
  • Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Patient with acute intestinal obstruction or sub-obstruction, history of inflammatory intestinal disease or extended resection of the small intestine or presence of a colic prosthesis.
  • Patient with unhealed wound, active oesogastric or duodenal ulcer, or bone fracture
  • Patient with an history of abdominal fistulas, trachea-esophageal fistulas or any other grade 4, gastro-intestinal perforations or non-gastrointestinal fistulas or intra-abdominal abscesses during the 6 months before randomization.
  • For patient treated with bevacizumab: patient with uncontrolled arterial hypertension (systolic pressure >150 mmHg and/or diastolic pressure >100 mmHg) with and without antihypertensive medication. Patients with high hypertension are eligible if antihypertensive medication lowers their arterial pressure to the level specified by the criterion.
  • Patient with an history of hypertensive crisis or hypertensive encephalopathy
  • Patient with other concomitant malignancy or history of cancer (except in situ carcinoma of the cervix, or non-melanoma skin cancer, treated with curative intent treatment) except if considered in complete remission for at least 2 years before randomization
  • Existence of any other pathology, metabolic problem, anomaly during the clinical examination or biological anomaly which may reasonable suspect an underlying pathology which would contra- indicate the use of the study medication or any other risk of complication related to the treatment.
  • Any treatment including an experimental drug, or participation in another clinical trial within 28 days before randomization.
  • Pregnant women, or women who could possibly be pregnant (or who expect to fall pregnant within 6 months of the end of treatment), or who are breast feeding are not eligible.
  • Men and women of child-bearing potential who do not accept to use a highly effective contraceptive (as per currently acceptable institutional standards) or abstinence during the study and for the month after the last administration of the study treatments.
  • Persons deprived of liberty or under guardianship.
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr MAYEUR
Prénom : Didier
Téléphone : Non disponible
Email : dmayeur@cgfl.fr
CONTACT TECHNIQUE
Nom : LE BERRE
Prénom : Kevin
Téléphone : 03 80 73 77 51
Email : kleberre@cgfl.fr

Référentiels Oncologik

  • Estomac