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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Ultra-sound Guided Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy: Randomized Controlled Trial.

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Drug: platelet rich plasma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: platelet rich plasma<br>patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve | Drug: platelet rich plasma<br>* perineural PRP injection under ultrasound guidance in addition to medical treatment<br>* Other names: medical treatment;|
| Sham Comparator: contact group<br>only medical treatment in form of opioid and NSAIDs will be used | Drug: platelet rich plasma<br>* perineural PRP injection under ultrasound guidance in addition to medical treatment<br>* Other names: medical treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 15 days, 1 month, 2 months, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total neuropathy score | 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 | 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 | baseline, 15 days, 1 month, 2 months, 3 months | 
| Nerve conduction study | To measure how fast the electrical impulses moves through the nerve. | 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 | baseline, 15 days, 1 month, 2 months, 3 months |