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.
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 previously started on PACLITAXEL
Known allergy to any of the substances in the study product Onlife®/placebo (fish oil product)
Diabetes
Exogenous (Alcoholism)
Parallel
OnLife®
DrugIt 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
Placebo
Other interventionIt 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
Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.
Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0. during the consultation with the oncologist at 3 months. The AE graded from 1 to 5. Grade 1 is a better and grade 5 is a worst outcome.
Evaluation of Neuropathic pain symptom inventory (NPSI) scores
Evaluation of Neuropathic pain symptom inventory scores by the questionnaire. The minimum value is 0 (no pain) and the maximum value is 10 (maximum pain)
All peripheral neuropathies graded by the oncologist according to CTCAE V5.0
Assess the rate of grade ≥ 2 peripheral neuropathy by NCI-CTCAE V5.0 The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.
Time to onset of grade ≥ 2 neuropathy.
Assess time to onset of grade ≥ 2 neuropathy by Kaplan-Meyer method The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.
Number of toxicities attributable to OnLife® dietary supplement
Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0
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