Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy

NCT05025826 | Active Not Recruiting

• 1 other identifier: RC21_0246
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 8

Brief Summary

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

Metastatic Gastric Cancer

Keywords

Oxaliplatin based chemotherapy; neurotoxicity

Outcome Measures

Primary Outcomes (1)

• 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

  4 months after oxaliplatin-based chemotherapy start

Secondary Outcomes (6)

• Comparison between the two arms of percentage of patients who stopped oxaliplatin for neurological toxicity

  last day of chemotherapy

• Comparison between the two arms of percentage of patients with oxaliplatin dose decrease

  last day of chemotherapy

• Comparison between the two arms of Neurological toxicities according to the Common Terminology Criteria for adverse Event (CTCAE) v5.0

  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…)

  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

  end of study visit (an average of 9 months after cycle 1 day1)

Study Arms (2)

Phycocare

EXPERIMENTAL

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

Other: Phycocare

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Phycocare OTHER

Phycocare every day during 9 months (except days of chemotherapy: no Phycocare)

Phycocare

Placebo OTHER

Placebo every day during 9 months (except days of chemotherapy = no Placebo)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Algosource: collaborator

Study Sites (8)

Clermont-Ferrand UH

Clermont-Ferrand, France, France

Location

Centre Hospitalier de Cholet

Cholet, 49300, France

Location

Chd La Roche Sur Yon

La Roche-sur-Yon, France

Location

Hôpital le Confluent

Nantes, 44000, France

Location

Nantes Uh

Nantes, France

Location

Saint Gregoire Clinique

Rennes, France

Location

Mutaliste Clinic Saint Nazaire

Saint-Nazaire, France

Location

Foch Suresnes Hosptial

Suresnes, France

Location

Related Publications (1)

• Le 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 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Yann TOUCHEFEU, Professor

  NANTES UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The placebo will match as much as possible all the characteristics of the Phycocare®
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm A: Phycocare Arm B: Placebo

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 27, 2021
• Study Start: April 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (8)