Cryotherapy for Neuropathy in Children

• Sponsor: South Valley University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04536207
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.4
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Cryotherapy (apparatus)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Double (Participant, Investigator)
• Masking Description: 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).
• Primary Purpose: Treatment
• Official Title: Effect of Cryotherapy in Controlling Peripheral Neuropathy in Cancer Children
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the study group Group (A) the study group received cryotherapy	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
No Intervention: the control group Group (B) the control group not received cryotherapy

Outcome Measures

Primary Outcome Measures

1. Nerve conduction studies (NCS) [nerve conduction velocity for sensory ulnar nerve at day 0]

   nerve conduction velocity for sensory ulnar nerve

2. Nerve conduction studies (NCS) [nerve conduction velocity for sensory ulnar nerve at day 90]

   nerve conduction velocity for sensory ulnar nerve

3. Nerve conduction studies (NCS) [nerve conduction velocity for sensory sensory median nerve at day 0]

   nerve conduction velocity for sensory median nerve

4. Nerve conduction studies (NCS) [nerve conduction velocity for sensory sensory median nerve at day 90]

   nerve conduction velocity for sensory median nerve

5. Nerve conduction studies (NCS) [nerve conduction velocity for sensory sural nerve at day 0]

   nerve conduction velocity for sensory sural nerve

6. Nerve conduction studies (NCS) [nerve conduction velocity for sensory sural nerve at day 90]

   nerve conduction velocity for sensory sural nerve

7. Nerve conduction studies (NCS) [nerve conduction velocity for motor common peroneal nerve at day 0]

   nerve conduction velocity for motor common peroneal nerve

8. Nerve conduction studies (NCS) [nerve conduction velocity for motor common peroneal nerve at day 90]

   nerve conduction velocity for motor common peroneal nerve

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Valley University, Faculty of Physical Therapy	Qina,		Egypt	83523

Sponsors and Collaborators

• South Valley University

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Aug 27, 2020

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Nehad Ahmed Youness Abo-zaid, Lecturer of physical therapy, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, South Valley University, Qena, Egypt., South Valley University
• ClinicalTrials.gov Identifier: NCT04536207
• Other Study ID Numbers: P.T.REC/012/002570
• First Posted: Sep 2, 2020
• Last Update Posted: Oct 15, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nehad Ahmed Youness Abo-zaid, Lecturer of physical therapy, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, South Valley University, Qena, Egypt., South Valley University: Cancer; Peripheral neuropathy; Cryotherapy

Study Results

No Results Posted as of Oct 15, 2021