Actively Recruiting
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
Led by Centre Georges Francois Leclerc · Updated on 2024-04-22
60
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer patient receiving neo-adjuvant or adjuvant treatment with an indication for weekly PACLITAXEL 80 mg/m² for 12 courses
- Age 18 years or older
- Karnofsky performance status of 3 or less and life expectancy over 6 months
- Effective contraception for patients of childbearing age during OnLife/placebo use
- Able to swallow OnLife/placebo tablets easily
- Willing and able to follow all study procedures including completing questionnaires
- Has understood, signed, and dated the consent form
- Affiliated with the social security system
You will not qualify if you...
- Previously started PACLITAXEL treatment
- Known allergy to any components of OnLife/placebo, including fish oil
- Diabetes
- Alcoholism
- History of peripheral neuropathy or neurological sensory or motor disorders
- Pregnant or breastfeeding
- Other uncontrolled progressive diseases
- Unable to follow up or random follow-up
- Persons under legal guardianship or deprived of liberty
- Unable to participate in medical follow-up due to geographical, social, or psychological reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Georges François Leclerc
Dijon, France, 21000
Actively Recruiting
Research Team
D
Didier MAYEUR, Doctor
CONTACT
E
Emilie REDERSTORFF
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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