Clinical trial NCT04536207: Cryotherapy for Neuropathy in Children
Official title: Effect of Cryotherapy in Controlling Peripheral Neuropathy in Cancer Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Cancer
Peripheral neuropathy
Cryotherapy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory ulnar nerve at day 0
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory ulnar nerve at day 90
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory sensory median nerve at day 0
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory sensory median nerve at day 90
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory sural nerve at day 0
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory sural nerve at day 90
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for motor common peroneal nerve at day 0
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for motor common peroneal nerve at day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Qina,
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
Study officials:
affiliation: South Valley University
name: Nehad A. Abo-zaid, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.
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. doi: 10.1007/s10549-016-3977-7. Epub 2016 Sep 12.
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.