Cryotherapy for Neuropathy in Children

October 13, 2021 updated by: Nehad Ahmed Youness Abo-zaid, South Valley University

Effect of Cryotherapy in Controlling Peripheral Neuropathy in Cancer Children

This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 non pharmacologic 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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohammed E Ali, Ph.D student
  • Phone Number: +201011212425
  • Email: m.essam@svu.edu.eg

Study Locations

  • Egypt
      • Qina,, Egypt, 83523
        • Recruiting
        • South Valley University, Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Their age will ranging from eight to seventeen years.
  2. Children participated in this study will from both sexes.
  3. Children receiving chemotherapy as medical treatment protocol
  4. All children have polyneuropathy caused by chemotherapy.

Exclusion Criteria:

  1. Children with Epilepsy.
  2. Children with blood clotting disorder.
  3. Children have Open wounds / broken skin
  4. Children with severe cardiac disease
  5. Uncooperative patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the study group
Group (A) the study group received cryotherapy
Other: Cryotherapy (apparatus)
Cryotherapy is a pain treatment that uses a method of localized freezing temperatures to deaden an irritated nerve. Cryotherapy is also used as a method of treating localized areas of some cancers (called cryosurgery), such as prostate cancer and to treat abnormal skin cells by dermatologists
No Intervention: the control group
Group (B) the control group not received cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for sensory ulnar nerve at day 0
nerve conduction velocity for sensory ulnar nerve
nerve conduction velocity for sensory ulnar nerve at day 0
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for sensory ulnar nerve at day 90
nerve conduction velocity for sensory ulnar nerve
nerve conduction velocity for sensory ulnar nerve at day 90
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for sensory sensory median nerve at day 0
nerve conduction velocity for sensory median nerve
nerve conduction velocity for sensory sensory median nerve at day 0
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for sensory sensory median nerve at day 90
nerve conduction velocity for sensory median nerve
nerve conduction velocity for sensory sensory median nerve at day 90
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for sensory sural nerve at day 0
nerve conduction velocity for sensory sural nerve
nerve conduction velocity for sensory sural nerve at day 0
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for sensory sural nerve at day 90
nerve conduction velocity for sensory sural nerve
nerve conduction velocity for sensory sural nerve at day 90
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for motor common peroneal nerve at day 0
nerve conduction velocity for motor common peroneal nerve
nerve conduction velocity for motor common peroneal nerve at day 0
Nerve conduction studies (NCS)
Time Frame: nerve conduction velocity for motor common peroneal nerve at day 90
nerve conduction velocity for motor common peroneal nerve
nerve conduction velocity for motor common peroneal nerve at day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

July 15, 2022

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

August 29, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P.T.REC/012/002570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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