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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Georges Francois Leclerc

About this trial

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

Qualifiers

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.

Disqualifiers

Patient previously started on PACLITAXEL

Known allergy to any of the substances in the study product Onlife®/placebo (fish oil product)

Diabetes

Exogenous (Alcoholism)

Trial design

Treatments tested in this trial

  • OnLife®
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups