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Nutritional Supplement for Treating Chemotherapy Induced Neuropathy

NCT ID: NCT07022938

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-12-15

Brief Summary

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Administration of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy

Detailed Description

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Investigation of effectiveness and safety of a nutritional supplement containing palmitoyethanolamide, alpha lipoic acid, vitamin B12, vitamin B6 , vitamin B1, nicotinamide, magnesium, zinc, vitamin E, and superoxide of dismutase in individuals receiving chemotherapy

Conditions

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Cancer Neuropathy Chemotherapy Induced Pain Neuropathy Chemotherapy-Induced Peripheral Neuropathy

Keywords

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cancer neuropathy chemotherapy induced neuropathy supplement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled placebo controlled study of a nutritional supplement intervention (epineuron) with 10 elements to investigate the effect in chemotherapy induced neuropathy
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Epineuron

Administration of a nutritional supplement with Palmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet

Group Type ACTIVE_COMPARATOR

Epineuron

Intervention Type DIETARY_SUPPLEMENT

Palmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet

Placebo

similar tablet without active ingredients

Group Type PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type DIETARY_SUPPLEMENT

placebo tablet without active ingredients

Interventions

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Epineuron

Palmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo Tablets

placebo tablet without active ingredients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed patients with cancer that have not received yet their treatment
* Patients that will be treated with platinum agents or taxanes

Exclusion Criteria

* Not receiving dietary supplement
* Have already neuropathy
* Have already started chemotherapy
* Patients with uncontrolled diabetes

\-- Patients with chronic kidney disease
* Patiens with recent cardiovascular incident
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Prof. Triantafyllos Didangelos

Professor of Internal Medicine and Diabetology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University General Hospital of Thessaloniki AHEPA

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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2606/25.1.2021

Identifier Type: -

Identifier Source: org_study_id