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NCT Number: NCT06543264

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

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

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Key information

Conditions

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

Location contact

Nehad A. Abo-zaid,, PHD

CONTACT

[email protected]

01223265216

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Nerve conduction studies (NCS)

    Time frame: nerve conduction velocity for sensory ulnar nerve at day 0

    nerve conduction velocity for sensory ulnar nerve

  2. Nerve conduction studies (NCS)

    Time frame: nerve conduction velocity for sensory ulnar nerve at day 90

    nerve conduction velocity for sensory ulnar nerve

  3. Nerve conduction studies (NCS)

    Time frame: nerve conduction velocity for sensory sensory median nerve at day 0

    nerve conduction velocity for sensory median nerve

  4. Nerve conduction studies (NCS)

    Time frame: nerve conduction velocity for sensory sensory median nerve at day 90

    nerve conduction velocity for sensory median nerve

Study contacts

Contact information is provided by the study sponsor or research team.

Walaa E Heneidy, PHD

CONTACT

[email protected]

+20127512697

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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