Cryotherapy for Neuropathy in Children

NCT04536207 | Unknown

• 1 other identifier: P.T.REC/012/002570
• 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

Keywords

Cancer; Peripheral neuropathy; Cryotherapy

Outcome Measures

Primary Outcomes (8)

• 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

• Nerve conduction studies (NCS)

  nerve conduction velocity for sensory sural nerve

  nerve conduction velocity for sensory sural nerve at day 0

• Nerve conduction studies (NCS)

  nerve conduction velocity for sensory sural nerve

  nerve conduction velocity for sensory sural nerve at day 90

• Nerve conduction studies (NCS)

  nerve conduction velocity for motor common peroneal nerve

  nerve conduction velocity for motor common peroneal nerve at day 0

• Nerve conduction studies (NCS)

  nerve conduction velocity for motor common peroneal nerve

  nerve conduction velocity for motor common peroneal nerve at day 90

Study Arms (2)

the study group

EXPERIMENTAL

Group (A) the study group received cryotherapy

Other: Cryotherapy (apparatus)

the control group

NO INTERVENTION

Group (B) the control group not received cryotherapy

Interventions

Cryotherapy (apparatus) OTHER

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

• South Valley University: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

RECRUITING

Related Publications (6)

• Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

  PMID: 25261162 BACKGROUND

• Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.

  PMID: 24733808 BACKGROUND

• Scotte F, Banu E, Medioni J, Levy E, Ebenezer C, Marsan S, Banu A, Tourani JM, Andrieu JM, Oudard S. Matched case-control phase 2 study to evaluate the use of a frozen sock to prevent docetaxel-induced onycholysis and cutaneous toxicity of the foot. Cancer. 2008 Apr 1;112(7):1625-31. doi: 10.1002/cncr.23333.

  PMID: 18286527 BACKGROUND

• Hanai A, Ishiguro H, Sozu T, Tsuda M, Yano I, Nakagawa T, Imai S, Hamabe Y, Toi M, Arai H, Tsuboyama T. Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. J Natl Cancer Inst. 2018 Feb 1;110(2):141-148. doi: 10.1093/jnci/djx178.

  PMID: 29924336 BACKGROUND

• Tsuyuki S, Senda N, Kanng Y, Yamaguchi A, Yoshibayashi H, Kikawa Y, Katakami N, Kato H, Hashimoto T, Okuno T, Yamauchi A, Inamoto T. Evaluation of the effect of compression therapy using surgical gloves on nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: a phase II multicenter study by the Kamigata Breast Cancer Study Group. Breast Cancer Res Treat. 2016 Nov;160(1):61-67. doi: 10.1007/s10549-016-3977-7. Epub 2016 Sep 12.

  PMID: 27620884 BACKGROUND

• Kadakia KC, Rozell SA, Butala AA, Loprinzi CL. Supportive cryotherapy: a review from head to toe. J Pain Symptom Manage. 2014 Jun;47(6):1100-15. doi: 10.1016/j.jpainsymman.2013.07.014. Epub 2013 Nov 7.

  PMID: 24210702 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Peripheral Nervous System Diseases

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nehad A. Abo-zaid, Ph.D

  South Valley University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nehad A. Abo-Zaid, Ph.D

CONTACT

+201223265216; dr.nehadahmed@svu.edu.eg

Mohammed E Ali, Ph.D student

CONTACT

+201011212425; m.essam@svu.edu.eg

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, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, South Valley University, Qena, Egypt.

Model Details: They were assigned randomly into two equal groups.Group (A) study group received the same medical care and cryotherapy, three times / weak for three successful months. And group (B) control group received medical care and standard chemotherapy only.

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: September 2, 2020
• Study Start: February 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 15, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)