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RECRUITING
NCT05695313
PHASE2

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

Sponsor: Centre Georges Francois Leclerc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Months - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-04-12

Completion Date

2026-06-30

Last Updated

2024-04-22

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Centre Georges François Leclerc

Dijon, France