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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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
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
Centre Georges François Leclerc
Dijon, France
RECRUITINGNeuropathies 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.
Time frame: At 3 months
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)
Time frame: 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.
Time frame: 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.
Time frame: During 1 year
Number of toxicities attributable to OnLife® dietary supplement
Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: During 1 year
Name of all concomitant treatments administered for neuropathy
By recording data in the eCRF for both arms
Time frame: 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)
Time frame: 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
Time frame: 16 weeks
The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.
By NCI-CTCAE V5.0
Time frame: During 1 year
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