Preventing nerve damage from Paclitaxel in breast cancer patients
Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
PHASE2 · Centre Georges Francois Leclerc · NCT05695313
This study is testing if a dietary supplement called OnLife can help prevent nerve damage in breast cancer patients receiving Paclitaxel chemotherapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Months and up |
| Sex | Female |
| Sponsor | Centre Georges Francois Leclerc (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05695313 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the OnLife dietary supplement in preventing neuropathy caused by weekly Paclitaxel chemotherapy in breast cancer patients. Participants will be randomly assigned to receive either the OnLife supplement or a placebo alongside their chemotherapy treatment. The goal is to reduce the incidence of dose reductions and interruptions in chemotherapy, thereby enhancing treatment efficacy and improving patients' quality of life. The supplement will be administered starting a few days before chemotherapy and continued for one month after its completion.
Who should consider this trial
Good fit: Ideal candidates are adult breast cancer patients scheduled to receive weekly Paclitaxel chemotherapy as part of their treatment plan.
Not a fit: Patients who have a history of peripheral neuropathy or are currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help maintain chemotherapy dosing and improve the quality of life for breast cancer patients undergoing treatment.
How similar studies have performed: While there have been studies on neuropathy prevention in chemotherapy, the specific use of OnLife as a dietary supplement in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dijon
- Centre Georges François Leclerc — Dijon, France (RECRUITING)
Study contacts
- Study coordinator: Didier MAYEUR, Doctor
- Email: dmayeur@cgfl.fr
- Phone: 03 80 73 75 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, breast, neuropathy, OnLife, dietary supplement, Paclitaxel