Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Substance Related Disorders

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Neurotoxicity Syndromes

Syndrome

Poisoning

Chemically-Induced Disorders

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Standard chemotherapy PACLITAXEL + placebo dietary supplement

Standard chemotherapy + OnLife® dietary supplement

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

OnLife®

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

Placebo

Didier MAYEUR, Doctor

Emilie REDERSTORFF

Didier MAYEUR, Dr

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.

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)

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

Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

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 scores by the questionnaire. The minimum value is 0 (no pain) and the maximum value is 10 (maximum pain)

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.

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.

Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0

Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification

Compliance with the Onlife®/Placebo dietary supplement will be assessed by the accounting for treatments returned by patients to the pharmacy.

Quality of life will be assessed by the EORTC QLQ C30 self-questionnaires and its associated module Chemotherapy-Induced Peripheral Neuropathy (CIPN 20).

The minimum value is 1 (no way) and the maximum value is 4 (a lot)

By recording data in the eCRF for both arms

Evaluation of ONLS scores by the questionnaires. The minimum value is 0 (better outcome) and the maximum value is 5 (worse outcome)

Compliance with the Onlife®/Placebo dietary supplement will be assessed by the Morisky questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL	NCT05695313	Breast Cancer	OnLife® Placebo	18 Months -	Centre Georges Francois Leclerc
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL	NCT05695313	Breast Cancer	OnLife® Placebo	18 Months -	Centre Georges Francois Leclerc

Spots Global Cancer Trial Database for onlife®

Every month we try and update this database with for onlife® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for onlife®

Every month we try and update this database with for onlife® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for onlife® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.