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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
OnLife®
Placebo
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast, neuropathy, OnLife, dietary supplement, Paclitaxel

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    OnLife®

    Arm Description

    Standard chemotherapy PACLITAXEL + placebo dietary supplement

    Standard chemotherapy + OnLife® dietary supplement

    Outcomes

    Primary Outcome Measures

    Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.
    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.

    Secondary Outcome Measures

    Evaluation of Neuropathic pain symptom inventory (NPSI) scores
    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)
    All peripheral neuropathies graded by the oncologist according to CTCAE V5.0
    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.
    Time to onset of grade ≥ 2 neuropathy.
    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.
    Number of toxicities attributable to OnLife® dietary supplement
    Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0
    Number of participants with musculoskeletal and joint pain
    Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification
    Compliance with the Onlife®/Placebo dietary supplement
    Compliance with the Onlife®/Placebo dietary supplement will be assessed by the accounting for treatments returned by patients to the pharmacy.
    Quality of life of participants
    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)
    The number and rate of women with at least one dose reduction due to peripheral neuropathy.
    By NCI-CTCAE V5.0
    Name of all concomitant treatments administered for neuropathy
    By recording data in the eCRF for both arms
    Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores
    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
    Compliance with the Onlife®/Placebo dietary supplement will be assessed by the Morisky questionnaire
    The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.
    By NCI-CTCAE V5.0

    Full Information

    First Posted
    January 2, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Centre Georges Francois Leclerc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05695313
    Brief Title
    Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
    Acronym
    NEUROTAX
    Official Title
    Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2026 (Anticipated)
    Study Completion Date
    April 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Georges Francois Leclerc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    breast, neuropathy, OnLife, dietary supplement, Paclitaxel

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Standard chemotherapy PACLITAXEL + placebo dietary supplement
    Arm Title
    OnLife®
    Arm Type
    Experimental
    Arm Description
    Standard chemotherapy + OnLife® dietary supplement
    Intervention Type
    Drug
    Intervention Name(s)
    OnLife®
    Intervention Description
    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
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.
    Description
    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.
    Time Frame
    At 3 months
    Secondary Outcome Measure Information:
    Title
    Evaluation of Neuropathic pain symptom inventory (NPSI) scores
    Description
    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)
    Time Frame
    At 12 weeks, 16 weeks, 6 months and 12 months
    Title
    All peripheral neuropathies graded by the oncologist according to CTCAE V5.0
    Description
    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.
    Time Frame
    Every 4 weeks for one year
    Title
    Time to onset of grade ≥ 2 neuropathy.
    Description
    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.
    Time Frame
    During 1 year
    Title
    Number of toxicities attributable to OnLife® dietary supplement
    Description
    Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0
    Time Frame
    Every 4 weeks for one year
    Title
    Number of participants with musculoskeletal and joint pain
    Description
    Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification
    Time Frame
    At 12 weeks, 16 weeks 6 months and 12 months.
    Title
    Compliance with the Onlife®/Placebo dietary supplement
    Description
    Compliance with the Onlife®/Placebo dietary supplement will be assessed by the accounting for treatments returned by patients to the pharmacy.
    Time Frame
    16 weeks
    Title
    Quality of life of participants
    Description
    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)
    Time Frame
    At baseline and then every 4 weeks for 4 months and then at 6 and 12 months.
    Title
    The number and rate of women with at least one dose reduction due to peripheral neuropathy.
    Description
    By NCI-CTCAE V5.0
    Time Frame
    During 1 year
    Title
    Name of all concomitant treatments administered for neuropathy
    Description
    By recording data in the eCRF for both arms
    Time Frame
    At 12 weeks, 16 weeks, 6 months and 12 months.
    Title
    Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores
    Description
    Evaluation of ONLS scores by the questionnaires. The minimum value is 0 (better outcome) and the maximum value is 5 (worse outcome)
    Time Frame
    At 12 weeks, 16 weeks, 6 months and 12 months
    Title
    Compliance with the Onlife®/Placebo dietary supplement
    Description
    Compliance with the Onlife®/Placebo dietary supplement will be assessed by the Morisky questionnaire
    Time Frame
    16 weeks
    Title
    The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.
    Description
    By NCI-CTCAE V5.0
    Time Frame
    During 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Didier MAYEUR, Doctor
    Phone
    03 80 73 75 00
    Ext
    +33
    Email
    dmayeur@cgfl.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emilie REDERSTORFF
    Phone
    03 80 73 75 00
    Ext
    +33
    Email
    erederstorff@cgfl.fr

    12. IPD Sharing Statement

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

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