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NCT05695313 | Not yet recruiting | Breast Cancer

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

Georges Francois Leclerc Center

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.

Condition or disease

Breast Cancer

Intervention/treatment

OnLife®

Placebo

Phase

Phase 2

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)}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
Actual Study Start Date : March 31, 2024
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026
Arm Intervention/treatment

Placebo Comparator: Placebo

Standard chemotherapy PACLITAXEL + placebo dietary supplement

Other: Placebo

Experimental: OnLife®

Standard chemotherapy + OnLife® dietary supplement

Drug: OnLife®
Ages Eligible for Study: 18 Months
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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.
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

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

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