Nutritional Supplement for Treating Chemotherapy Induced Neuropathy

Aristotle University Of Thessaloniki71 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cancer Neuropathy Chemotherapy Induced Pain Neuropathy Chemotherapy-Induced Peripheral Neuropathy

Interventions

EpineuronDIETARY_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 TabletsDIETARY_SUPPLEMENT

placebo tablet without active ingredients

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University General Hospital of Thessaloniki AHEPA

Thessaloniki, Greece

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 6 months

Secondary Outcomes

Visual Analogue scale

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

Time frame: 6 months

Nerve conduction velocity

neurophysiological assessment of sural nerve

Time frame: 6months

Vibration perception threshold

Vibration perception threshold was measured with biothesiometer

Time frame: 6 months

Data from ClinicalTrials.gov

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