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Metastatic Gastric CancerPROPERTYNCT05025826

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

A study testing Phycocare in people with Metastatic Gastric Cancer, run by Nantes University Hospital at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Gastric Cancer
What is being tested?
Phycocare
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
8 sitesFrance
Study dates
1 Apr 2022to 14 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 18Show fewer
  • 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

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Centre Hospitalier de Cholet

    Cholet, 49300

  • Clermont-Ferrand UH

    Clermont-Ferrand

  • Chd La Roche Sur Yon

    La Roche-sur-Yon

  • Hôpital le Confluent

    Nantes, 44000

  • Nantes Uh

    Nantes

  • Saint Gregoire Clinique

    Rennes

  • Mutaliste Clinic Saint Nazaire

    Saint-Nazaire

  • Foch Suresnes Hosptial

    Suresnes

Other trials in France

About this study

Official title: Randomized, Double-blind, Multicenter Placebo-controlled Study Evaluating Neurotoxicity in Patients With Metastatic Gastro Intestinal Cancer Taking Phycocare® or Placebo During Oxaliplatin Based Chemotherapy

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.

Read more

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.

Read the detailed description

The phycocyanin used in this protocol (Phycocare®) will be 5 times more concentrated than the Spirulysat (food supplement commercialized by Algosource).

It will be administrated during Oxaliplatin based chemotherapy and 3 months after oxaliplatin stopped.

Being tested
Phycocare, Placebo
Keywords
Oxaliplatin based chemotherapy, neurotoxicity
Medical subject headings
Stomach Neoplasms, Neurotoxicity Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhycocareOther

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

  • PlaceboOther

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

Study groups in NCT05025826
Study groupRoleWhat they receive
PhycocareExperimentalPHYCOCARE 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
Receives: Other: Phycocare
PlaceboPlacebo comparatorPlacebo 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
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 months after oxaliplatin-based chemotherapy start

Secondary outcomes (6)

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

    Delay of definitive interruption or decrease of oxaliplatin treatment

    Measured: last day of chemotherapy

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

    Dose intensity of oxaliplatin

    Measured: last day of chemotherapy

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

    Neurological AE at following hospital visit : baseline, M4 and M9/end of study visit

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

  4. Comparison between the two arms of Overall Toxicity (including hematological toxicity, gastro-intestinal toxicity, etc…)

    Adverse events grade 1 to 4

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

  5. Comparison between the two arms of Patient 's Quality of Life according with EORTC-QLQ-C30

    QLQ C30 - score questions 1 to 28: score frame [30-114] . 30= good quality of life questions 29 and 30 : score frame [2-14] . 2 = bad quality of lifre

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

  6. Comparison between the two arms of Neurological toxicities

    ElectroNeuroMyography (ENMG) and neurology questionnaire ONLS (overall neuropathy limitations scale)

    ONLS score:

    • sub-score upper limbs : [0-5] . 5= worst neuropathic injury
    • sub score lower limbs [0-7]: 7= worst neuropathic injury
    • total score = upper limbs score + lower limbs score [0-12] ; 0= no injury; 12= maximal incapacity

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start1 Apr 2022
  3. Primary completion14 Jan 2026
  4. Study completion14 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Arm A: Phycocare Arm B: Placebo
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05025826
Sponsor's protocol ID
RC21_0246
Acronym
PROPERTY
Status last verified
Jun 2026
First submitted
23 Jul 2021
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36670495

Questions about this trial

What is this clinical trial studying?

A study testing Phycocare in people with Metastatic Gastric Cancer, run by Nantes University Hospital at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demonstrate a 50% decrease of the grade> or = 2 neurotoxicity at 4 months after oxaliplatin-based chemotherapy start in the PHYCOCARE arm (time frame: 4 months after oxaliplatin-based chemotherapy start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05025826, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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