Chemotherapy-induced Peripheral Neuropathy
Conditions
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.
Interventions
DRUGplatelet rich plasma
perineural PRP injection under ultrasound guidance in addition to medical treatment
Sponsors
South Egypt Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| total neuropathy score | 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 |
| 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 |
| Nerve conduction study | baseline, 3 months | To measure how fast the electrical impulses moves through the nerve. |
| 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 |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORNayira Mahmoud Elhusseini, MSc
South Egypt Cancer Institute, Assuit university
Outcome results
None listed