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

Sponsor
South Egypt Cancer Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05348408
Collaborator
(none)
62
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: platelet rich plasma
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Ultra-sound Guided Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy: Randomized Controlled Trial.
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in severity of pain after injection [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 Outcome Measures

    1. total neuropathy score [baseline, 15 days, 1 month, 2 months, 3 months]

      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

    2. The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx) [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 [baseline, 3 months]

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

    4. A 7- point Likert like verbal rating scale [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • South Egypt Cancer Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nayira Mahmoud El-Husseini, Assistant lecturer of Anesthesia, ICU and pain releis, South Egypt Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05348408
    Other Study ID Numbers:
    • 573
    First Posted:
    Apr 27, 2022
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Apr 27, 2022