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

S

South Egypt Cancer Institute

Status and phase

Unknown
Phase 2

Conditions

Chemotherapy-induced Peripheral Neuropathy

Treatments

Drug: platelet rich plasma

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

62 participants in 2 patient groups

platelet rich plasma
Active Comparator group
Description:
patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve
Treatment:
Drug: platelet rich plasma
contact group
Sham Comparator group
Description:
only medical treatment in form of opioid and NSAIDs will be used
Treatment:
Drug: platelet rich plasma

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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