NCT05695313

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: Female
• Age: 18 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
OTHER	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

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-01-25
• Last updated: 2024-04-22

Locations

1 site across 1 country: France