Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Substance Related Disorders

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Neurotoxicity Syndromes

Syndrome

Poisoning

Chemically-Induced Disorders

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Standard chemotherapy PACLITAXEL + placebo dietary supplement

Standard chemotherapy + OnLife® dietary supplement

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®

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

Didier MAYEUR, Doctor

Emilie REDERSTORFF

Didier MAYEUR, Dr

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.

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)

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

Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

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.

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)

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.

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.

Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0

Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification

Compliance with the Onlife®/Placebo dietary supplement will be assessed by the accounting for treatments returned by patients to the pharmacy.

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)

By recording data in the eCRF for both arms

Evaluation of ONLS scores by the questionnaires. The minimum value is 0 (better outcome) and the maximum value is 5 (worse outcome)

Compliance with the Onlife®/Placebo dietary supplement will be assessed by the Morisky questionnaire

Centre Georges Francois Leclerc

Peripheral Nervous System Diseases

Breast Diseases

Skin Diseases

Herbal and Botanical

Oxaliplatin

Cola

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult colon cancer patients who experienced a CIPN after adjuvant oxaliplatin-containing chemotherapy.

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult breast cancer patients who experienced a CIPN after adjuvant paclitaxel regimen.

Daily dosing of dietary supplement OnLife

OnLife

Matthias Zaiss, Dr.

The objective of this observational study is to evaluate the effectiveness of the dietary supplementation "OnLife" in improving signs and symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in adult patients who have finished adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer). Furthermore, patient-reported outcomes (PROs) and concomitant medication used for the treatment of neuropathic pain will be assessed.

CIPN is a common side effect of many chemotherapeutic agents and often results in dose limitation, switch to less efficacious agents or even therapy discontinuation. CIPN mainly affects sensory nerves, while motor or autonomic nerve injury is rare. Therefore, most patients with CIPN experience numbness, tingling, hyperesthesia, loss of vibratory perception, and burning pain. Due to the vulnerability of the long nerves, CIPN typically appears in a 'stocking and glove' distribution.

Chemotherapeutic agents that cause CIPN include platinum compounds (e.g., cisplatin, oxaliplatin), antitubulins (vinca alkaloids (e.g., vincristine) and taxanes (e.g., docetaxel, paclitaxel)), proteasome inhibitors (e.g., bortezomib) and immunomodulatory drugs (e.g., lenalidomide).

Platinum compounds are known to accumulate in the dorsal root ganglion (DRG) leading to cell death in sensory neurons. DRG death may account for chronic sensory neuropathy, which manifests primarily as sensory paresthesias, dysesthesias and sensory ataxia most often located in the extremities and persists between cycles. In addition, Oxaliplatin directly regulates the gating of axonal voltage-gated sodium channels, inducing an acute neurotoxicity which is characterized by peripheral nerve hyperexcitability. Symptoms, like sensitivities to touching cold items, discomfort swallowing cold liquids, throat discomfort, and muscle cramps, occur during or shortly after the infusion.

Taxanes are known to cause disruption of microtubule function and therefore microtubule-based axonal transport. In addition, they interfere with macrophage activation in both the DRG and peripheral nerve, as well as microglial activation within the spinal cord. These effects result in a distal axonopathy also referred to as the dying-back phenomenon.

The effectiveness of OnLife® in improving CIPN is based on a patented fatty acid group (FAG) that comprises palmitoylethanolamide (PEA), alpha-linolenic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), linoleic acid, oleic acid, palmitic acid, stearic acid, arachidic acid and myristic acid.

PEA, one main component of OnLife®, is an endogenous fatty acid amide belonging to the class of endocannabinoids and has been shown to have anti-inflammatory, antinociceptive, neuroprotective and anticonvulsant properties. It is synthesized in response to several inflammatory and painful disorders (e.g., intestinal inflammation and neuropathic pain) in order to counteract these pathological states. Clinical research revealed that treatment with exogenous PEA is effective and safe in various neuropathological conditions, including chronic idiopathic axonal neuropathy, diabetic neuropathy, nerve compression syndromes, as well as chemotherapy-induced neuropathic pain.

PEA exerts its analgesic and anti-inflammatory functions in the peripheral nervous system through its action on sensory neurons and on non-neuronal cells involved in inflammation, such as mast cells and macrophages. It indirectly activates cannabinoid receptor signaling by inhibiting the hydrolysis of endocannabinoids. This suppresses nociceptive behaviors and counteracts macrophage and mast cell activation, thereby reducing pain and other inflammatory symptoms. Another biological target of PEA is the nuclear peroxisome proliferator-activated receptor (PPAR)-alpha, expressed in various cells implicated in peripheral nociception, including dorsal DRG neurons and macrophages. Binding of PEA to PPAR-alpha ultimately results in reduced transcription of pro-inflammatory genes (e.g., TNF-alpha, IL-6, COX-2, iNOS) as well as repressed activity of pro-inflammatory transcription factors. In addition, there is some evidence that binding of PEA to PPAR-alpha may modulate excitability of primary sensory neurons by direct and indirect mechanisms.

The other fatty acids included in OnLife® have also been shown to have anti-inflammatory properties.

Currently, a study evaluating the efficacy and safety of OnLife® in patients with CIPN is carried out at the St. Savvas Anticancer Hospital, Athens by Dr. J. Skarlatos. First results suggest that OnLife® is reducing pain, numbness and tingle and improving heat/cold sensitivity as assessed by the physician. PRO, using the DN4 (Douleur Neuropathique 4) questionnaire, revealed a reduction of the score for diagnosing neuropathic pain during OnLife® application. Moreover, no patient showed a product-related side effect (date on file, unpublished).

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

An Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving Chemotherapy-induced peripherAl NeurOpathy in Patients With Colon or Breast Cancer After End of Adjuvant Therapy

Incidence of grade 0/1/2/3/4 peripheral sensory and/ or motor neuropathy according to CTCAE v4.03 after end of adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer)

Questionnaire EORTC QLQ-C30 is used to determine patients' health-related quality of life.

Questionnaire EORTC QLQ-CIPN20 is used to elicit patients' experience of symptoms and functional limitations related to CIPN.

Drug treatment of neuropathic pain is observed over the time of the OnLife® application and the month after the end of OnLife® application

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL	NCT05695313	Breast Cancer	OnLife® Placebo	18 Months -	Centre Georges Francois Leclerc
Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy	NCT03065478	CIPN in Adjuvan... CIPN in Adjuvan...	OnLife	18 Years -	Swiss Medical Food AG
Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL	NCT05695313	Breast Cancer	OnLife® Placebo	18 Months -	Centre Georges Francois Leclerc

Spots Global Cancer Trial Database for onlife

Every month we try and update this database with for onlife cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for onlife

Every month we try and update this database with for onlife cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for onlife cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.