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

Primary Purpose

Peripheral Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The Shock wave Therapy.
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring PERIPHERAL NEUROPATHY, CHEMOTHERAPY, SHOCKWAVE

Eligibility Criteria

8 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Valley University, Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The shockwave Group

the traditional treatment group

Arm Description

Group (A) study group received medical care and standard chemotherapy and shock wave, three times / week for three successful months.

group (B) control group received medical care and standard chemotherapy only.

Outcomes

Primary Outcome Measures

Malondialdehyde (MDA) as oxidative stress marker
Malondialdehyde level in blood will be measured
Malondialdehyde (MDA) as oxidative stress marker
Malondialdehyde level in blood will be measured
Interlukin 6 (IL-6) as inflammatory marker
Interlukin 6 (IL-6) level in blood will be measured
Interlukin 6 (IL-6) as inflammatory marker
Interlukin 6 (IL-6) level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Plasma Neurotensin (NT) level in blood will be measured
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Plasma Neurotensin (NT) level in blood will be measured

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
October 28, 2021
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05111730
Brief Title
Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients
Official Title
Effect of Shock Wave In Reducing Chemotherapy- Induced Peripheral Neuropathy In Adult and Pediatric Tumors Patients:A Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
PERIPHERAL NEUROPATHY, CHEMOTHERAPY, SHOCKWAVE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eighty children with tumors were enrolled in this study and were assessed for eligibility. Their aged ranged from eight and forty years. They were assigned randomly into two equal groups. Group (A) study group received the same medical care and shock wave, three times / weak for three successful months. And group (B) control group received medical care and standard chemotherapy only.Nerve conduction studies (NCS) and somatosensory-evoked potentials (SSEPs) were used to assess peripheral neuropathy pre and post intervention. All children were assisted before and after three months of intervention.
Masking
Outcomes Assessor
Masking Description
Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (study group) and Group B ( control group).
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The shockwave Group
Arm Type
Experimental
Arm Description
Group (A) study group received medical care and standard chemotherapy and shock wave, three times / week for three successful months.
Arm Title
the traditional treatment group
Arm Type
No Intervention
Arm Description
group (B) control group received medical care and standard chemotherapy only.
Intervention Type
Device
Intervention Name(s)
The Shock wave Therapy.
Intervention Description
Shockwave therapy is a multidisciplinary device used in orthopedics, physiotherapy, sports medicine, urology and veterinary medicine. Its main assets are fast pain relief and mobility restoration. Together with being a non-surgical therapy with no need for painkillers makes it an ideal therapy to speed up recovery and cure various indications causing acute or chronic pain. Shockwave is an acoustic wave which carries high energy to painful spots and myoskeletal tissues with sub-acute, sub-chronic and chronic conditions. The energy promotes regeneration and reparative processes of the bones, tendons and other soft tissues. Shockwaves are characterized by jump change in pressure, high amplitude and non-periodicity. The kinetic energy of the projectile, created by compressed air, is transferred to the transmitter at the end of the applicator and further into the tissue.
Primary Outcome Measure Information:
Title
Malondialdehyde (MDA) as oxidative stress marker
Description
Malondialdehyde level in blood will be measured
Time Frame
Malondialdehyde (MDA) level was assessed at day 0.
Title
Malondialdehyde (MDA) as oxidative stress marker
Description
Malondialdehyde level in blood will be measured
Time Frame
Malondialdehyde (MDA) level will be assessed at day 90.
Title
Interlukin 6 (IL-6) as inflammatory marker
Description
Interlukin 6 (IL-6) level in blood will be measured
Time Frame
Interlukin 6 (IL-6) level was assessed at day 0.
Title
Interlukin 6 (IL-6) as inflammatory marker
Description
Interlukin 6 (IL-6) level in blood will be measured
Time Frame
Interlukin 6 (IL-6) level will be assessed at day 90.
Title
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Description
Plasma Neurotensin (NT) level in blood will be measured
Time Frame
Plasma Neurotensin (NT)level was assessed at day 0.
Title
Plasma Neurotensin (NT) as potential marker for neuropathic pain
Description
Plasma Neurotensin (NT) level in blood will be measured
Time Frame
Plasma Neurotensin (NT)level will be assessed at day 90.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed E Ali, Ph.D student
Phone
01011212425
Email
m.essam@svu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Nehad A. Abo-zaid, Ph.D
Phone
+201223265216
Email
dr.nehadahmed@svu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed E Ali, Ph.D student
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qinā
State/Province
Qina
ZIP/Postal Code
83523
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed E. Ali., Ph.D student
Phone
01011212425
Email
m.essam@svu.edu.eg
First Name & Middle Initial & Last Name & Degree
Nehad A. Abo-zaid, Ph.D
Phone
+201223265216
Email
dr.nehadahmed@svu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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