Overview

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

Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Georges Francois Leclerc
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 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 Criteria:

- 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.