Nutritional Supplement for Treating Chemotherapy Induced Neuropathy

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

Conditions: Chemotherapy Induced Pain Neuropathy; Chemotherapy-Induced Peripheral Neuropathy; Cancer; Neuropathy

Treatments: Dietary Supplement: Epineuron; Dietary Supplement: Placebo Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT07022938

2606/25.1.2021

Details and patient eligibility

About

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

Full 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

Enrollment: 71 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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71 participants in 2 patient groups, including a placebo group

Epineuron

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Epineuron

Placebo

Placebo Comparator group

Description:

similar tablet without active ingredients

Treatment:

Dietary Supplement: Placebo Tablets