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

NCT05348408 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 573
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• total neuropathy score

  baseline, 15 days, 1 month, 2 months, 3 months

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

  baseline, 15 days, 1 month, 2 months, 3 months

• Nerve conduction study

  baseline, 3 months

• A 7- point Likert like verbal rating scale

  baseline, 15 days, 1 month, 2 months, 3 months

Study Arms (2)

platelet rich plasma

ACTIVE COMPARATOR

patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve

Drug: platelet rich plasma

contact group

SHAM COMPARATOR

only medical treatment in form of opioid and NSAIDs will be used

Drug: platelet rich plasma

Interventions

platelet rich plasma DRUG

perineural PRP injection under ultrasound guidance in addition to medical treatment

Also known as: medical treatment

contact group; platelet rich plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cancer patients with peripheral neuropathy confirmed by clinical evaluation and nerve conduction study despite of medical treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

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

Asyut, Egypt, 71514, Egypt

Location

Study Officials

• Nayira Mahmoud Elhusseini, MSc

  South Egypt Cancer Institute, Assuit university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesia, ICU and pain releis

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 27, 2022
• Study Start: April 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 24, 2026

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)