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 cehemotherapy, thus potentially improving the results in terms of antitumor efficacy while improving the quality of life of patients treated with weekly PACLITAXEL.
Two treatment arms :
\- ARM A : 20 patients included in the placebo arm (Standard chemotherapy with PACLITAXEL + placebo dietary supplement) ARM B : 40 patients included in the experimental arm (standard PACLITAXEL chemotherapy + OnLife® food supplement)
Age
1–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
