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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Standard chemotherapy PACLITAXEL + placebo dietary supplement |
|
| OnLife® | Experimental | Standard chemotherapy + OnLife® dietary supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnLife® | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Didier MAYEUR, Doctor | Contact | 03 80 73 75 00 | +33 | dmayeur@cgfl.fr |
| Emilie REDERSTORFF | Contact | 03 80 73 75 00 | +33 | erederstorff@cgfl.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Recruiting | Dijon | 21000 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Placebo | Other | 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 |
|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |