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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | similar tablet without active ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue scale | scale for pain , higher values indicate more severity of pain, scale 0-100 | 6 months |
| Nerve conduction velocity | neurophysiological assessment of sural nerve |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Thessaloniki AHEPA | Thessaloniki | Greece |
Data privacy of participants
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Randomised controlled placebo controlled study of a nutritional supplement intervention (epineuron) with 10 elements to investigate the effect in chemotherapy induced neuropathy
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| Placebo Tablets | Dietary Supplement | placebo tablet without active ingredients |
|
| 6months |
| Vibration perception threshold | Vibration perception threshold was measured with biothesiometer | 6 months |