Cancer, Chemotherapy Induced Pain Neuropathy, Chemotherapy-Induced Peripheral Neuropathy, Neuropathy
Conditions
Keywords
cancer, neuropathy, chemotherapy induced neuropathy, supplement
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
Detailed description
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
Interventions
DIETARY_SUPPLEMENTEpineuron
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_SUPPLEMENTPlacebo Tablets
placebo tablet without active ingredients
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomised controlled placebo controlled study of a nutritional supplement intervention (epineuron) with 10 elements to investigate the effect in chemotherapy induced neuropathy
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Symptom Inventory | 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. |
| PAIN Detect score | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue scale | 6 months | scale for pain , higher values indicate more severity of pain, scale 0-100 |
| Nerve conduction velocity | 6months | neurophysiological assessment of sural nerve |
| Vibration perception threshold | 6 months | Vibration perception threshold was measured with biothesiometer |
Countries
Greece
Outcome results
None listed