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Trial Title:
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
NCT ID:
NCT05695313
Condition:
Breast Cancer
Conditions: Official terms:
Neurotoxicity Syndromes
Conditions: Keywords:
breast
neuropathy
OnLife
dietary supplement
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
OnLife®
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
Arm group label:
OnLife®
Intervention type:
Other
Intervention name:
Placebo
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
Arm group label:
Placebo
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)
Criteria for 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.
Gender:
Female
Minimum age:
18 Months
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Recruiting
Contact:
Last name:
Didier MAYEUR, Dr
Email:
dmayeur@cgfl.fr
Start date:
April 12, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Centre Georges Francois Leclerc
Agency class:
Other
Source:
Centre Georges Francois Leclerc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05695313
