Clinical trial NCT05695313: Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
Official title: Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast
neuropathy
OnLife
dietary supplement
Paclitaxel
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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)

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.

Primary outcomes:
measure: Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.
timeFrame: At 3 months
Secondary outcomes:
measure: Evaluation of Neuropathic pain symptom inventory (NPSI) scores
timeFrame: At 12 weeks, 16 weeks, 6 months and 12 months
measure: All peripheral neuropathies graded by the oncologist according to CTCAE V5.0
timeFrame: Every 4 weeks for one year
measure: Time to onset of grade ≥ 2 neuropathy.
timeFrame: During 1 year
measure: Number of toxicities attributable to OnLife® dietary supplement
timeFrame: Every 4 weeks for one year
measure: Number of participants with musculoskeletal and joint pain
timeFrame: At 12 weeks, 16 weeks 6 months and 12 months.
measure: Compliance with the Onlife®/Placebo dietary supplement
timeFrame: 16 weeks
measure: Quality of life of participants
timeFrame: At baseline and then every 4 weeks for 4 months and then at 6 and 12 months.
measure: The number and rate of women with at least one dose reduction due to peripheral neuropathy.
timeFrame: During 1 year
measure: Name of all concomitant treatments administered for neuropathy
timeFrame: At 12 weeks, 16 weeks, 6 months and 12 months.
measure: Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores
timeFrame: At 12 weeks, 16 weeks, 6 months and 12 months
measure: Compliance with the Onlife®/Placebo dietary supplement
timeFrame: 16 weeks
measure: The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.
timeFrame: During 1 year
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
Study officials:
References: