RecruitingPhase 2NCT05695313

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

Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

Sponsor

Centre Georges Francois Leclerc

Enrollment

60 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 Months

Inclusion Criteria8

Breast cancer patient with neo-adjuvant or adjuvant management, with an indication for weekly PACLITAXEL 80 mg/m² for 12 courses.
Age ≥ 18 years
Performans Status ≤ 3 according to Karnofsky and life expectancy greater than 6 months
For patients of childbearing age, effective contraception while taking Onlife®/placebo.
Patient able to swallow OnLife/placebo® tablets easily
Patient able and willing to follow all study procedures (including the completion of numerous questionnaires) in accordance with the protocol
Patient has understood, signed and dated the consent form
Patient affiliated to the social security system

Exclusion Criteria10

Patient previously started on PACLITAXEL
Known allergy to any of the substances in the study product Onlife®/placebo (fish oil product)
Diabetes
Exogenous (Alcoholism)
History of peripheral neuropathy at inclusion and/or presence of sensory and/or motor disorders due to other neurological diseases
Pregnant or breastfeeding woman
Other uncontrolled progressive pathologies
Impossible or random follow-up
Persons 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.

Interventions

DRUGOnLife®

It is administered for the duration of PACLITAXEL chemotherapy with the first administration performed 5 days before the first PACLITAXEL administration. The OnLife supplement will be continued for another 4 weeks after the last PACLITAXEL administration. One tablet in the morning and one in the evening daily

OTHERPlacebo

It is administered for the duration of PACLITAXEL chemotherapy with the first administration performed 5 days before the first PACLITAXEL administration. Placebo will be continued for another 4 weeks after the last PACLITAXEL administration. One tablet in the morning and one in the evening daily