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Cryotherapy for Neuropathy in Children

NCT ID: NCT04536207

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-07-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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).

Study Groups

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the study group

Group (A) the study group received cryotherapy

Group Type EXPERIMENTAL

Cryotherapy (apparatus)

Intervention Type 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 control group

Group (B) the control group not received cryotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Nehad Ahmed Youness Abo-zaid

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nehad A. Abo-zaid, Ph.D

Role: PRINCIPAL_INVESTIGATOR

South Valley University

Locations

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South Valley University, Faculty of Physical Therapy

Qina, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nehad A. Abo-Zaid, Ph.D

Role: CONTACT

[email protected]
+201223265216

Mohammed E Ali, Ph.D student

Role: CONTACT

[email protected]
+201011212425

Facility Contacts

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Nehad A Abo-zaid, Lecturer

Role: primary

[email protected]
01223265216

References

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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.

Reference Type BACKGROUND
PMID: 25261162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24733808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18286527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29924336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27620884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24210702 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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P.T.REC/012/002570

Identifier Type: -

Identifier Source: org_study_id