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

NCT ID: NCT05695313

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-12
• Study Completion Date: 2026-06-30

Brief 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.

Detailed 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)

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Placebo

Standard chemotherapy PACLITAXEL + placebo dietary supplement

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

It 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

OnLife®

Standard chemotherapy + OnLife® dietary supplement

Group Type: EXPERIMENTAL

OnLife®

Intervention Type: DRUG

It 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

Interventions

OnLife®

It 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

Intervention Type: DRUG

Placebo

It 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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Months
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Georges François Leclerc

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Didier MAYEUR, Doctor

Role: CONTACT

dmayeur@cgfl.fr

03 80 73 75 00 ext. +33

Emilie REDERSTORFF

Role: CONTACT

erederstorff@cgfl.fr

03 80 73 75 00 ext. +33

Facility Contacts

Didier MAYEUR, Dr

Role: primary

dmayeur@cgfl.fr

Other Identifiers

2022-A01940-43

Identifier Type: -

Identifier Source: org_study_id