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This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the study group | Experimental | Group (A) the study group received cryotherapy |
|
| the control group | No Intervention | Group (B) the control group not received cryotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Nehad A. Abo-zaid, Ph.D | South Valley University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Valley University, Faculty of Physical Therapy | Recruiting | Qina | 83523 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25261162 | Background | 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. | |
| 24733808 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2020 | Aug 29, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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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).
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nerve conduction velocity for motor common peroneal nerve |
| nerve conduction velocity for motor common peroneal nerve at day 90 |
| 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. |
| 18286527 | 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. |
| 29924336 | 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. |
| 27620884 | 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. |
| 24210702 | 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. |