Back to resultsEfficacy of Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy.
Primary Purpose
Chemotherapy-induced Peripheral Neuropathy
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
platelet rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
platelet rich plasma
contact group
Arm Description
patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve
only medical treatment in form of opioid and NSAIDs will be used
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Nerve conduction study
To measure how fast the electrical impulses moves through the nerve.
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
Full Information
NCT ID
NCT05348408
First Posted
April 13, 2022
Last Updated
April 20, 2022
Sponsor
South Egypt Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05348408
Brief Title
Efficacy of Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy.
Official Title
Efficacy of Ultra-sound Guided Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy: Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
platelet rich plasma
Arm Type
Active Comparator
Arm Description
patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve
Arm Title
contact group
Arm Type
Sham Comparator
Arm Description
only medical treatment in form of opioid and NSAIDs will be used
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma
Other Intervention Name(s)
medical treatment
Intervention Description
perineural PRP injection under ultrasound guidance in addition to medical treatment
Primary Outcome Measure Information:
Title
Change in severity of pain after injection
Description
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
Time Frame
baseline, 15 days, 1 month, 2 months, 3 months
Secondary Outcome Measure Information:
Title
total neuropathy score
Description
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
Time Frame
baseline, 15 days, 1 month, 2 months, 3 months
Title
The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx)
Description
a 27 questionnaire that measure health related quality of life in patients with cancer ad chronic illnesses
Time Frame
baseline, 15 days, 1 month, 2 months, 3 months
Title
Nerve conduction study
Description
To measure how fast the electrical impulses moves through the nerve.
Time Frame
baseline, 3 months
Title
A 7- point Likert like verbal rating scale
Description
extremely dissatisfied = 1, dissatisfied = 2, somewhat dissatisfied = 3, undecided = 4, somewhat satisfied = 5, satisfied = 6 and extremely satisfied = 7
Time Frame
baseline, 15 days, 1 month, 2 months, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy.
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