Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

NCT05695313 | Recruiting Phase 2

• 1 other identifier: 2022-A01940-43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast; neuropathy; OnLife; dietary supplement; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Evaluation of Neuropathic pain symptom inventory (NPSI) scores

  At 12 weeks, 16 weeks, 6 months and 12 months

• All peripheral neuropathies graded by the oncologist according to CTCAE V5.0

  Every 4 weeks for one year

• Time to onset of grade ≥ 2 neuropathy.

  During 1 year

• Number of toxicities attributable to OnLife® dietary supplement

  Every 4 weeks for one year

• Number of participants with musculoskeletal and joint pain

  At 12 weeks, 16 weeks 6 months and 12 months.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Standard chemotherapy PACLITAXEL + placebo dietary supplement

Other: Placebo

OnLife®

EXPERIMENTAL

Standard chemotherapy + OnLife® dietary supplement

Drug: OnLife®

Interventions

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

OnLife®

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

Placebo

Eligibility Criteria

• Age: 18 Months+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient previously started on PACLITAXEL
• Known allergy to any of the substances in the study product Onlife®/placebo (fish oil product)
• Diabetes
• Exogenous (Alcoholism)
• 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.

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Didier MAYEUR, Doctor

CONTACT

03 80 73 75 00; dmayeur@cgfl.fr

Emilie REDERSTORFF

CONTACT

03 80 73 75 00; erederstorff@cgfl.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 25, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

FR (1)