Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients

Not Applicable

• Conditions: Peripheral Neuropathy
• Interventions: Device: The Shock wave Therapy.

• Registration Number: NCT05111730
• Lead Sponsor: South Valley University

Brief Summary

This study aimed to assess the efficacy of shock wave in reducing Chemotherapy- Induced Peripheral Neuropathy in adult and pediatric tumors patients.

Detailed Description

Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and nonpharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Study Start: 2021-12-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Their age will ranging from eight to forty years.
• All cases participated in this study will from both sexes.
• All cases receiving chemotherapy as primary treatment, postoperative surgical removal of tumors or with conjunction with radiotherapy
• All cases have polyneuropathy caused by chemotherapy.

Exclusion Criteria

• Patient with osteoporosis.
• Patient with DVT.
• Patient have a Pacemaker fitted
• Uncooperative patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The shockwave Group	The Shock wave Therapy.	Group (A) study group received medical care and standard chemotherapy and shock wave, three times / week for three successful months.

Primary Outcome Measures

Name	Time	Method
Malondialdehyde (MDA) as oxidative stress marker	Malondialdehyde (MDA) level will be assessed at day 90.	Malondialdehyde level in blood will be measured
Interlukin 6 (IL-6) as inflammatory marker	Interlukin 6 (IL-6) level will be assessed at day 90.	Interlukin 6 (IL-6) level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic pain	Plasma Neurotensin (NT)level will be assessed at day 90.	Plasma Neurotensin (NT) level in blood will be measured

Trial Locations

Locations (1)

South Valley University, Faculty of Physical Therapy; 🇪🇬 Qinā, Qina, Egypt