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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05348408
• Other study ID #: 573
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2022
• Est. completion date: April 2024

Study information

• Verified date: April 2022
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: April 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• platelet rich plasma
perineural PRP injection under ultrasound guidance in addition to medical treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Nerve conduction study	To measure how fast the electrical impulses moves through the nerve.	baseline, 3 months
Secondary	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