Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phycocare | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phycocare
- description
- 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
- interventionNames
- Other: Phycocare
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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
- interventionNames
- Other: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDLe Gouill-Jaijarat C, Pereon Y, Leroy M, Lepine O, Loloum A, Peluchon C, Volteau C, Martineau AS, Korner S, Perrault C, Benmaziane A, Girot P, Petorin C, Perret C, Ligeza-Poisson C, Mayeur D, Flet L, Chiffoleau A, Poinas A, Bennouna J. PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE(R) during oxaliplatin-based chemotherapy. Trials. 2023 Jan 20;24(1):50. doi: 10.1186/s13063-023-07071-z. PMID 36670495