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Completed

NCT Number: NCT05348408

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Asyut, Egypt, 71514

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet rich plasma

Drug

perineural PRP injection under ultrasound guidance in addition to medical treatment

Other names: medical treatment

Primary outcomes

  1. Change in severity of pain after injection

    Time frame: 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 outcomes

  1. total neuropathy score

    Time frame: baseline, 15 days, 1 month, 2 months, 3 months

    Peripheral neuropathy severity assessed using the reduced version of the Total Neuropathy Score (TNSr) due to feasibility and resource limitations

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

    Time frame: 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

  3. Nerve conduction study

    Time frame: baseline, 3 months

    To measure how fast the electrical impulses moves through the nerve.

  4. A 7- point Likert like verbal rating scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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