Nutritional Supplement for Treating Chemotherapy Induced Neuropathy

Phase 4

Completed

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

• Registration Number: NCT07022938
• Lead Sponsor: Aristotle University Of Thessaloniki

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 Timeline

• Study Start: 2021-11-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-08
• Last Update Submitted: 2025-06-08
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neuropathic Pain Symptom Inventory	6 months	scale for neuropathic pain symptoms
PAIN Detect score	6 months	score for neuropathic pain

Secondary Outcome Measures

Name	Time	Method
Visual Analogue scale	6 months	scale for pain
Nerve conduction velocity	6months	neurophysiological assessment of sural nerve
Vibration perception threshold	6 months	Vibration perception threshold was measured with biothesiometer

Trial Locations

Locations (1)

University General Hospital of Thessaloniki AHEPA; 🇬🇷 Thessaloniki, Greece