Efficacy of Cryotherapy in Managing Chemotherapy-Induced Peripheral Neuropathy in Children With Leukemia

August 8, 2024 updated by: walaa eldesoukey heneidy, Delta University for Science and Technology
This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children

Study Overview

Status

Not yet 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 (Estimated)

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

Study Locations

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

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

  • Child

Accepts Healthy Volunteers

No

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
Cryotherapy (apparatus)
Device: Cryotherapy
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
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

Collaborators and Investigators

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

Sponsor

Delta University for Science and Technology

Investigators

  • Principal Investigator: Nehad A. Abo-zaid, PHD, South Valley University

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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

August 4, 2024

First Submitted That Met QC Criteria

August 4, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cryotherapy and Leukemia

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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