Evaluating the effects of Phycocare on nerve damage in metastatic gastric cancer patients undergoing 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

This study is testing if a supplement called Phycocare can help reduce nerve damage caused by chemotherapy in patients with advanced stomach cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Drugs / interventions: bevacizumab, cetuximab, panitumumab, nivolumab, Trastuzumab, chemotherapy
• Locations: 9 sites (Cholet and 8 other locations)
• Trial ID: NCT05025826 on ClinicalTrials.gov

What this trial studies

This study investigates the potential protective effects of Phycocare®, a concentrated phycocyanin supplement, against chemotherapy-induced peripheral neuropathy (CIPN) in patients with metastatic gastrointestinal cancer receiving oxaliplatin-based chemotherapy. Participants will be randomly assigned to receive either Phycocare® or a placebo during their chemotherapy treatment and for three months after treatment ends. The study aims to assess whether Phycocare® can reduce the incidence and severity of CIPN, which is a common and debilitating side effect of cancer treatment. The research will involve thorough eligibility screening and monitoring of patients throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically or cytologically proven metastatic gastrointestinal cancer who are scheduled to receive oxaliplatin-based chemotherapy.

Not a fit: Patients who have previously received treatment for their metastatic disease or those with a life expectancy of less than 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive approach to reduce nerve damage in cancer patients undergoing chemotherapy.

How similar studies have performed: While there is limited research specifically on Phycocare®, studies on similar antioxidant compounds have shown promise in reducing chemotherapy-induced side effects.

Eligibility criteria

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.

Where this trial is running

Cholet and 8 other locations

• Centre Hospitalier de Cholet — Cholet, France (Recruiting)
• Clermont-Ferrand UH — Clermont-Ferrand, France (Recruiting)
• Dijon Uh — Dijon, France (Withdrawn)
• Chd La Roche Sur Yon — La Roche-sur-Yon, France (Recruiting)
• Hôpital le Confluent — Nantes, France (Recruiting)
• Nantes Uh — Nantes, France (Recruiting)
• Saint Gregoire Clinique — Rennes, France (Recruiting)
• Mutaliste Clinic Saint Nazaire — Saint-Nazaire, France (Recruiting)
• Foch Suresnes Hosptial — Suresnes, France (Recruiting)

Study contacts

• Principal investigator: Yann TOUCHEFEU, Professor — Nantes Uh
• Study coordinator: Yann TOUCHEFEU, Professor

Conditions Metastatic Gastric Cancer; Oxaliplatin based chemotherapy; neurotoxicity