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OpenTrials
Completed

NCT Number: NCT07022938

Nutritional Supplement for Treating Chemotherapy Induced Neuropathy

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

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Key information

Conditions

Cancer Chemotherapy Induced Pain Neuropathy Chemotherapy-induced Peripheral Neuropathy Neoplasms Neuropathy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University General Hospital of Thessaloniki AHEPA

Thessaloniki, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo tablets

Dietary Supplement

placebo tablet without active ingredients

Primary outcomes

  1. Neuropathic Pain Symptom Inventory

    Time frame: 6 months

    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.

  2. PAIN Detect score

    Time frame: 6 months

    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

Secondary outcomes

  1. Visual Analogue scale

    Time frame: 6 months

    scale for pain , higher values indicate more severity of pain, scale 0-100

  2. Nerve conduction velocity

    Time frame: 6months

    neurophysiological assessment of sural nerve

  3. Vibration perception threshold

    Time frame: 6 months

    Vibration perception threshold was measured with biothesiometer

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Efficacy and Safety of a Tablet Containing Palmitoyethanolamide, Alpha Lipoic Acid, Vitamin B12, Vitamin B6 , Vitamin B1, Nicotinamide, Magnesium, Zinc, Vitamin E, and Superoxide of Dismutase in Individuals Receiving Chemotherapy

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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