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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- Neuropathic Pain Symptom Inventory
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts 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
Arms & Interventions
Epineuron
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
Intervention: Epineuron (Dietary Supplement)
Placebo
similar tablet without active ingredients
Intervention: Placebo Tablets (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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
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.
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
- Nerve conduction velocity(6months)
- Nerve conduction velocity(6months)
- Visual Analogue scale(6 months)
- Vibration perception threshold(6 months)
Investigators
Prof. Triantafyllos Didangelos
Professor of Internal Medicine and Diabetology
Aristotle University Of Thessaloniki