Breast CancerPhase 2NEUROTAXNCT05695313
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
A Phase 2 study testing OnLife® in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- OnLife®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Georges François Leclerc
Dijon, 21000
Didier MAYEUR, Dr, dmayeur@cgfl.fr
About this study
Official title: Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
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.
Read the 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)
- Conditions
- Breast Cancer
- Being tested
- OnLife®, Placebo
- Keywords
- breast, neuropathy, OnLife, dietary supplement, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Standard chemotherapy PACLITAXEL + placebo dietary supplement Receives: Other: Placebo |
| OnLife® | Experimental | Standard chemotherapy + OnLife® dietary supplement Receives: Drug: OnLife® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months
Secondary outcomes (12)
Evaluation of Neuropathic pain symptom inventory (NPSI) scores
Evaluation of Neuropathic pain symptom inventory scores by the questionnaire. The minimum value is 0 (no pain) and the maximum value is 10 (maximum pain)
Measured: At 12 weeks, 16 weeks, 6 months and 12 months
All peripheral neuropathies graded by the oncologist according to CTCAE V5.0
Assess the rate of grade ≥ 2 peripheral neuropathy by NCI-CTCAE V5.0 The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.
Measured: Every 4 weeks for one year
Time to onset of grade ≥ 2 neuropathy.
Assess time to onset of grade ≥ 2 neuropathy by Kaplan-Meyer method The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.
Measured: During 1 year
Number of toxicities attributable to OnLife® dietary supplement
Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0
Measured: Every 4 weeks for one year
Number of participants with musculoskeletal and joint pain
Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification
Measured: At 12 weeks, 16 weeks 6 months and 12 months.
Compliance with the Onlife®/Placebo dietary supplement
Compliance with the Onlife®/Placebo dietary supplement will be assessed by the accounting for treatments returned by patients to the pharmacy.
Measured: 16 weeks
Quality of life of participants
Quality of life will be assessed by the EORTC QLQ C30 self-questionnaires and its associated module Chemotherapy-Induced Peripheral Neuropathy (CIPN 20).
The minimum value is 1 (no way) and the maximum value is 4 (a lot)
Measured: At baseline and then every 4 weeks for 4 months and then at 6 and 12 months.
The number and rate of women with at least one dose reduction due to peripheral neuropathy.
By NCI-CTCAE V5.0
Measured: During 1 year
Name of all concomitant treatments administered for neuropathy
By recording data in the eCRF for both arms
Measured: At 12 weeks, 16 weeks, 6 months and 12 months.
Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores
Evaluation of ONLS scores by the questionnaires. The minimum value is 0 (better outcome) and the maximum value is 5 (worse outcome)
Measured: At 12 weeks, 16 weeks, 6 months and 12 months
Compliance with the Onlife®/Placebo dietary supplement
Compliance with the Onlife®/Placebo dietary supplement will be assessed by the Morisky questionnaire
Measured: 16 weeks
The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.
By NCI-CTCAE V5.0
Measured: During 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start12 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695313
- Sponsor's protocol ID
- 2022-A01940-43
- Acronym
- NEUROTAX
- Status last verified
- Apr 2024
- First submitted
- 2 Jan 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL
- ClinicalTrials.gov ID
- NCT05695313
- Acronym / sponsor ID
- NEUROTAX / 2022-A01940-43
- Conditions
- Breast Cancer
- Keywords
- breast, neuropathy, OnLife, dietary supplement, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboStandard chemotherapy PACLITAXEL + placebo dietary supplement |
| OnLife® | Experimental | Drug: OnLife®Standard chemotherapy + OnLife® dietary supplement |
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnLife®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 | Drug | OnLife® |
| PlaceboIt 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 | Other | Placebo |
Primary outcome
Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.
Time frame: At 3 months
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.
12 secondary outcomes
Evaluation of Neuropathic pain symptom inventory (NPSI) scores
Time frame: At 12 weeks, 16 weeks, 6 months and 12 months
All peripheral neuropathies graded by the oncologist according to CTCAE V5.0
Time frame: Every 4 weeks for one year
Time to onset of grade ≥ 2 neuropathy.
Time frame: During 1 year
Number of toxicities attributable to OnLife® dietary supplement
Time frame: Every 4 weeks for one year
Number of participants with musculoskeletal and joint pain
Time frame: At 12 weeks, 16 weeks 6 months and 12 months.
Compliance with the Onlife®/Placebo dietary supplement
Time frame: 16 weeks
Quality of life of participants
Time frame: At baseline and then every 4 weeks for 4 months and then at 6 and 12 months.
The number and rate of women with at least one dose reduction due to peripheral neuropathy.
Time frame: During 1 year
Name of all concomitant treatments administered for neuropathy
Time frame: At 12 weeks, 16 weeks, 6 months and 12 months.
Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores
Time frame: At 12 weeks, 16 weeks, 6 months and 12 months
Compliance with the Onlife®/Placebo dietary supplement
Time frame: 16 weeks
The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.
Time frame: During 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OnLife® in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier MAYEUR, Doctor (03 80 73 75 00 ext. +33, dmayeur@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0. (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.