Nutritional Supplement for Treating Chemotherapy Induced Neuropathy

NCT07022938 | Completed Phase 4

• 1 other identifier: 2606/25.1.2021
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Cancer; Neuropathy; Chemotherapy Induced Pain Neuropathy

Keywords

cancer; neuropathy; chemotherapy induced neuropathy; supplement

Outcome Measures

Primary Outcomes (2)

• Neuropathic Pain Symptom Inventory

  scale for neuropathic pain symptoms. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. In addition, we propose to derive five subscores corresponding to the mean scores of the items belonging to each of the five factors identified in the factor analysis. three questions based on clinical examination to evaluate the intensity of pain evoked by brushing, pressure, cold or warm stimuli in the painful area on four-point categorical scales (absent, mild, moderate, severe). Clinical examination of evoked pain was standardized: tactile allodynia was evaluated with a soft brush (three movements), pressure allodynia was evoked by blunt pressure with a finger at a pressure that does not provoke pain in a normal area and glass tubes filled with hot (38-408C) or cold (22-248C) water were used to evaluate thermal allodynia.

  6 months

• PAIN Detect score

  score for neuropathic pain, higher values indicate that the pain is neuropathic. A Pain DETECT score between-1 and 38 indicates the likelihood of a neuropathic pain component

  6 months

Secondary Outcomes (3)

• Visual Analogue scale

  6 months

• Nerve conduction velocity

  6months

• Vibration perception threshold

  6 months

Study Arms (2)

Epineuron

ACTIVE COMPARATOR

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

Dietary Supplement: Epineuron

Placebo

PLACEBO COMPARATOR

similar tablet without active ingredients

Dietary Supplement: Placebo Tablets

Interventions

Epineuron 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

Epineuron

Placebo Tablets DIETARY_SUPPLEMENT

placebo tablet without active ingredients

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

University General Hospital of Thessaloniki AHEPA

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine and Diabetology

Model Details: Randomised controlled placebo controlled study of a nutritional supplement intervention (epineuron) with 10 elements to investigate the effect in chemotherapy induced neuropathy

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: November 1, 2021
• Primary Completion: January 31, 2025
• Study Completion: December 15, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)