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
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-08
• Study First Posted: 2025-06-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09

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. 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 Outcome Measures

Name	Time	Method
Nerve conduction velocity	6months	neurophysiological assessment of sural nerve
Visual Analogue scale	6 months	scale for pain , higher values indicate more severity of pain, scale 0-100
Vibration perception threshold	6 months	Vibration perception threshold was measured with biothesiometer

Trial Locations

Locations (1)

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