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

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Drug: platelet rich plasma

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Egypt
    • Asyut, Egypt, Egypt, 71514
      • Pain clinic and intervention unit at South Egypt Cancer Institute, Assuit University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
total neuropathy score	Peripheral neuropathy severity assessed using the reduced version of the Total Neuropathy Score (TNSr) due to feasibility and resource limitations	baseline, 15 days, 1 month, 2 months, 3 months

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Principal Investigator: Nayira Mahmoud Elhusseini, MSc, South Egypt Cancer Institute, Assuit university

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes