Informations générales (source: ClinicalTrials.gov)
Randomized, Double-blind, Multicenter Placebo-controlled Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy (PROPERTY)
Interventional
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
avril 2022
mars 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 21/10/2024 07:07:22 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chd La Roche Sur Yon - La Roche-sur-Yon - France | Paul GIROT, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de Cholet - 49300 - Cholet - France | Victor SIMMET, MD | Contact (sur clinicalTrials) | |||
| Clermont-Ferrand UH - Clermont-Ferrand - France | Caroline PETORIN, MD | Contact (sur clinicalTrials) | |||
| DIJON UH - Dijon - France | Contact (sur clinicalTrials) | ||||
| Hôpital le Confluent - 44000 - Nantes - France | Hélène CASTANIE, MD | Contact (sur clinicalTrials) | |||
| Mutaliste Clinic Saint Nazaire - Saint-Nazaire - France | Catherine Ligeza- Poisson, MD | Contact (sur clinicalTrials) | |||
| Nantes Uh - Nantes - France | Yann TOUCHEFEU, Professor | Contact (sur clinicalTrials) | |||
| Saint Gregoire Clinique - Rennes - France | Clément PERRET, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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, pancreatic cancers, locally advanced 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
- 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, pancreatic cancers, locally advanced 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
- 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.
- Known allergy or hypersensitivity to antibodies or any preservatives if patient is
treated with a monoclonal antibody combined to chemotherapy (bevacizumab or
cetuximab or panitumumab or nivolumab or Trastuzumab For patients treated with
trastuzumab : patient without HER2 overexpression (defined by positive IHC3 or
positive IHC2 and confirmed by a positive FISH result)
- 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.