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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: OnLife®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Standard chemotherapy PACLITAXEL + placebo dietary supplement | Other: Placebo<br>* 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<br>|
| Experimental: OnLife®<br>Standard chemotherapy + OnLife® dietary supplement | Drug: OnLife®<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At 12 weeks, 16 weeks, 6 months and 12 months | 
| 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. | Every 4 weeks for one year | 
| 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. | During 1 year | 
| Number of toxicities attributable to OnLife® dietary supplement | Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0 | Every 4 weeks for one year | 
| Number of participants with musculoskeletal and joint pain | Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification | At 12 weeks, 16 weeks 6 months and 12 months. | 
| 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. | 16 weeks | 
| 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) | At baseline and then every 4 weeks for 4 months and then at 6 and 12 months. | 
| The number and rate of women with at least one dose reduction due to peripheral neuropathy. | By NCI-CTCAE V5.0 | During 1 year | 
| Name of all concomitant treatments administered for neuropathy | By recording data in the eCRF for both arms | At 12 weeks, 16 weeks, 6 months and 12 months. | 
| 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) | At 12 weeks, 16 weeks, 6 months and 12 months | 
| Compliance with the Onlife®/Placebo dietary supplement | Compliance with the Onlife®/Placebo dietary supplement will be assessed by the Morisky questionnaire | 16 weeks | 
| The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy. | By NCI-CTCAE V5.0 | During 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast, neuropathy, OnLife, dietary supplement, Paclitaxel