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Not Yet Recruiting NCT05695313

Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

Conditions: Breast Cancer

Sex: Female
Ages: 18 Months – N/A
Phase: PHASE2
Enrollment: 60
Sponsor: Centre Georges Francois Leclerc

Summary

This study recommends the use of OnLife dietary supplement, which will be followed by a few day before the initiation of PACLITAXEL, for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy.This would limit the number of PACLITAXEL dose reductions and premature interruptions of this chemotherapy, thus potentially improving the results in terms of antitumor efficacy, while improving the quality of life of patients treated with weekly PACLITAXEL.

Eligibility Criteria

Inclusion Criteria:Breast cancer patient with neo-adjuvant or adjuvant management, with an indication for weekly PACLITAXEL 80 mg/m² for 12 courses.Age ≥ 18 yearsPerformans Status ≤ 3 according to Karnofsky and life expectancy greater than 6 monthsFor patients of childbearing age, effective contraception while taking Onlife®/placebo.Patient able to swallow OnLife/placebo® tablets easilyPatient able and willing to follow all study procedures (including the completion of numerous questionnaires) in accordance with the protocolPatient has understood, signed and dated the consent formPatient affiliated to the social security systemExclusion Criteria:Patient previously started on PACLITAXELKnown allergy to any of the substances in the study product Onlife®/placebo (fish oil product)DiabetesExogenous (Alcoholism)History of peripheral neuropathy at inclusion and/or presence of sensory and/or motor disorders due to other neurological diseasesPregnant or breastfeeding womanOther uncontrolled progressive pathologiesImpossible or random follow-upPersons deprived of liberty or under guardianship (including curatorship)Inability to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05695313). StuddyBuddy aggregates publicly available trial information.