Cryotherapy for Neuropathy in Children

Cancer Clinical Trial

Official title:

Effect of Cryotherapy in Controlling Peripheral Neuropathy in Cancer Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04536207
• Other study ID #: P.T.REC/012/002570
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2021
• Source: South Valley University
• Contact: Nehad A. Abo-Zaid, Ph.D
• Phone: +201223265216
• Email: dr.nehadahmed[@]svu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 15, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Egypt	South Valley University, Faculty of Physical Therapy	Qina,

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Scotté 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. — View Citation

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. Review. — View Citation

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. Epub 2016 Sep 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for sensory ulnar nerve	nerve conduction velocity for sensory ulnar nerve at day 0
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for sensory ulnar nerve	nerve conduction velocity for sensory ulnar nerve at day 90
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for sensory median nerve	nerve conduction velocity for sensory sensory median nerve at day 0
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for sensory median nerve	nerve conduction velocity for sensory sensory median nerve at day 90
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for sensory sural nerve	nerve conduction velocity for sensory sural nerve at day 0
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for sensory sural nerve	nerve conduction velocity for sensory sural nerve at day 90
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for motor common peroneal nerve	nerve conduction velocity for motor common peroneal nerve at day 0
Primary	Nerve conduction studies (NCS)	nerve conduction velocity for motor common peroneal nerve	nerve conduction velocity for motor common peroneal nerve at day 90