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

Phase 2

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Drug: platelet rich plasma

• Registration Number: NCT05348408
• Lead Sponsor: South Egypt Cancer Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2022-04
• Study Start: 2022-04
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27
• Primary Completion: 2023-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet rich plasma	platelet rich plasma	patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve
contact group	platelet rich plasma	only medical treatment in form of opioid and NSAIDs will be used

Primary Outcome Measures

Name	Time	Method
Change in severity of pain after injection	baseline, 15 days, 1 month, 2 months, 3 months	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

Secondary Outcome Measures

Name	Time	Method
total neuropathy score	baseline, 15 days, 1 month, 2 months, 3 months	used by non neurologists in oncology practice setting, includes items that quantify pinprick sensation, tuning fork-based vibration thershold, deep tendon reflex, strength. score range 0-28
The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx)	baseline, 15 days, 1 month, 2 months, 3 months	a 27 questionnaire that measure health related quality of life in patients with cancer ad chronic illnesses
Nerve conduction study	baseline, 3 months	To measure how fast the electrical impulses moves through the nerve.
A 7- point Likert like verbal rating scale	baseline, 15 days, 1 month, 2 months, 3 months	extremely dissatisfied = 1, dissatisfied = 2, somewhat dissatisfied = 3, undecided = 4, somewhat satisfied = 5, satisfied = 6 and extremely satisfied = 7