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

Centre Georges Francois Leclerc

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Other: Placebo; Drug: OnLife®

Study type: Interventional

Funder types: Other

Identifiers

NCT05695313

2022-A01940-43

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Standard chemotherapy PACLITAXEL + placebo dietary supplement

Treatment:

Other: Placebo

OnLife®

Experimental group

Description:

Standard chemotherapy + OnLife® dietary supplement

Treatment:

Drug: OnLife®