Efficacy of Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy

South Egypt Cancer Institute62 enrolled

Overview

This study aims to show the efficacy and safety of ultra-sound guided peri-neural platelet rich injection in treatment of chemotherapy induced peripheral neuropathy.

This study is prospective, randomized, assessor blinded controlled trial. It is aims to study the effect of perineural platelet rich plasma injection in cancer patients with prepheral neuropathy despite of stoppage chemotherapy for 6 months and usage of medical treatment. Ultrasound-guided PRP injection will be performed after preparation of plasma obtained from the patient by using 10-19 MHz high frequency linear transducer to scan the superficial nerves.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

platelet rich plasmaDRUG

perineural PRP injection under ultrasound guidance in addition to medical treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * cancer patients with peripheral neuropathy confirmed by clinical evaluation and nerve conduction study despite of medical treatment Exclusion Criteria: patients with: * Foot ulcers and / or amputation. * Peripheral vascular disease. * Uncontrolled diabetes * Vertebral pathologies. * Connective tissue diseases. * Thyriod disorders, significant renal or hepatic dysfunction. * Platelet dysfunction syndrome, critical thrombocytopenia. * Septicemia and local infection at the site of the procedure. * Systemic corticosteriod adminstiration or local injection at the suspected treatment site within the last month. * Recent fever or illness. * Hemoglobin level less than 10 g/dl, platelet count less than 105-109/L.

Locations (1)

Pain clinic and intervention unit at South Egypt Cancer Institute, Assuit University

Asyut, Egypt, Egypt

Outcomes

Primary Outcomes

Change in severity of pain after injection

Change in severity of pain after prp injection wii be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 =worst imaginable pain

Time frame: baseline, 15 days, 1 month, 2 months, 3 months

Secondary Outcomes

total neuropathy score

Peripheral neuropathy severity assessed using the reduced version of the Total Neuropathy Score (TNSr) due to feasibility and resource limitations

Time frame: baseline, 15 days, 1 month, 2 months, 3 months

The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx)

a 27 questionnaire that measure health related quality of life in patients with cancer ad chronic illnesses

Time frame: baseline, 15 days, 1 month, 2 months, 3 months

Nerve conduction study

To measure how fast the electrical impulses moves through the nerve.

Time frame: baseline, 3 months

A 7- point Likert like verbal rating scale

extremely dissatisfied = 1, dissatisfied = 2, somewhat dissatisfied = 3, undecided = 4, somewhat satisfied = 5, satisfied = 6 and extremely satisfied = 7

Time frame: baseline, 15 days, 1 month, 2 months, 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.