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

NCT06543264 | Not Yet Recruiting

• 1 other identifier: Cryotherapy and Leukemia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• Nerve conduction studies (NCS)

  nerve conduction velocity for sensory ulnar nerve

  nerve conduction velocity for sensory ulnar nerve at day 0

• Nerve conduction studies (NCS)

  nerve conduction velocity for sensory ulnar nerve

  nerve conduction velocity for sensory ulnar nerve at day 90

• Nerve conduction studies (NCS)

  nerve conduction velocity for sensory median nerve

  nerve conduction velocity for sensory sensory median nerve at day 0

• Nerve conduction studies (NCS)

  nerve conduction velocity for sensory median nerve

  nerve conduction velocity for sensory sensory median nerve at day 90

Study Arms (2)

the study group

EXPERIMENTAL

Cryotherapy (apparatus)

Device: Cryotherapy

the control group

NO INTERVENTION

not received cryotherapy

Interventions

Cryotherapy DEVICE

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

the study group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with Epilepsy.
• Children with blood clotting disorder.
• Children have Open wounds / broken skin
• Children with severe cardiac disease
• Uncooperative patients.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nehad A. Abo-zaid, PHD

  South Valley University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walaa E Heneidy, PHD

CONTACT

+20127512697; walaa.eldesoukey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single (Outcomes Assessor) 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 (control group) and Group B (study group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy for Pediatrics

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)