Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients

NCT05294380 | Unknown DMC

• 1 other identifier: TÜTF-BAEK 2021/389
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In children, both malnutrition and sarcopenia are associated with prolongation of hospital stay, increased morbidity, mortality, and health-related complications. While the decrease in muscle strength refers to "probable sarcopenia", "sarcopenia" is confirmed by adding the decrease in muscle quantity/quality to this situation. In case all three criteria are together, "severe sarcopenia" is mentioned. The aim of this study is the evaluate whether there is a difference in the risk of sarcopenia and related factors in pediatric oncological children compared to healthy controls matched for body mass index group, physical activity level group, sex, and age. Our research was planned as cross-sectional and descriptive research. Patients diagnosed with pediatric oncologic cancer will be included. Demographic data, malnutrition, the risk for sarcopenia, physical activity status, smartphone addiction, fatigue, and hospital anxiety and depression will be evaluated with questionnaires. Muscle strength (manual muscle strength assessment), Muscle quantity (the bilateral calf circumference with a tape measure and by bioelectrical impedance analysis (BIA)), and physical performance (Short Physical Performance Battery) will be evaluated by the physiotherapist. The data of the research will be evaluated with the SPSS package program. After examining the conformity of the data that can be measured in statistical evaluations to a normal distribution with a single sample Kolmogorov Smirnov test, one-way analysis of variance will be applied for comparisons between groups for those with normal distribution, and t-test for independent groups. Kruskal Wallis analysis of variance and Mann Whitney U test will be used in the evaluation of data that do not conform to the normal distribution. Pearson χ2 and Yates corrected Pearson χ2 test Fisher's exact χ2 will be used for qualitative data. As descriptive statistics, numbers and percentages will be given for categorical data, and Median (Min-Max) values and arithmetic mean±standard deviation will be given for quantitative data. For all statistics, the limit of significance will be chosen as bidirectional p\<0.05.

Conditions

Sarcopenia; Pediatric Cancer

Keywords

sarcopenia; Smartphone Addiction; Pediatric Cancer; Hematologic Malignancy; Anxiety Depression; bioelectrical impedance analysis

Outcome Measures

Primary Outcomes (3)

• Muscle quantity.

  Bioelectrical impedance analysis (BIA) has been explored for estimation of total or Appendicular Skeletal Muscle Mass (ASM). BIA equipment does not measure muscle mass directly, but instead derives an estimate of muscle mass based on whole-body electrical conductivity. BIA uses a conversion equation that is calibrated with a reference of DXA-measured lean mass in a specific population. BIA equipment is affordable, widely available, and portable, especially single-frequency instruments. Muscle quantity will be determined by measuring the bilateral calf circumference with a tape measure and by BIA, which is considered one of the main standard tools for sarcopenia case-finding in clinical practice. Whole-body skeletal muscle mass (SMM) or Appendicular skeletal muscle mass (ASMM) predicted by BIA.

  Seven months

• Physical performance

  Physical performance will be determined by Short Physical Performance Battery (SPPB). The SPPB is a composite test that includes assessment of gait speed, a balance test, and a chair stand test.

  Seven months

• Muscle strength.

  Upper extremities (manual muscle strength assessment), the lower extremities will be evaluated (by manual muscle strength assessment and chair rise test). The chair stand test (also called chair rise test) can be used as a proxy for strength of leg muscles (quadriceps muscle group). The chair stand test measures the amount of time needed for a patient to rise five times from a seated position without using his or her arms; the timed chair stand test is a variation that counts how many times a patient can rise and sit in the chair over a 30-second interval. Since the chair stand test requires both strength and endurance, this test is a qualified but convenient measure of strength.

  Seven months

Secondary Outcomes (8)

• Symptoms or signs of sarcopenia

  Seven months

• The presence of malnutrition

  Seven months

• Physical activity for parent

  Seven months

• Physical activity for preschool children and school-age children and adolescents

  Seven months

• Physical activity for elementary 4-8th grades

  Seven months

Study Arms (2)

oncologic

Be between the ages of 2-18 years Being under pediatric oncology outpatient/clinical follow-up Being able to stand unaided without using a cane/walker Exclusion criteria; Having any of the diagnoses of hypertension, any cardiac arrhythmia-conduction disorders, coronary artery disease, heart failure, diabetes mellitus, hyperlipidemia, cardiovascular diseases, COPD, pulmonary infection, active infection. Depression Illness that causes balance problems Peripheral vascular disease Presence of disease that prevents standing up with support Presence of diseases that may cause muscle mass loss (cerebral palsy, neuromuscular disease, congenital metabolic disorder, brain damage) mental retardation Children with a severe emotional disorder, adjustment disorder Physical disability to prevent safe and appropriate testing Having used anti-flu medicine in the last 1 week Failure to obtain consent

control

Be between the ages of 2-18 years Exclusion criteria; Having any of the diagnoses of hypertension, any cardiac arrhythmia-conduction disorders, coronary artery disease, heart failure, diabetes mellitus, hyperlipidemia, cardiovascular diseases, COPD, pulmonary infection, active infection. Depression Illness that causes balance problems Peripheral vascular disease Presence of disease that prevents standing up with support Presence of diseases that may cause muscle mass loss (cerebral palsy, neuromuscular disease, congenital metabolic disorder, brain damage) mental retardation Children with a severe emotional disorder, adjustment disorder Physical disability to prevent safe and appropriate testing Having used anti-flu medicine in the last 1 week Failure to obtain consent

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants, who meet inclusion and exclusion criteria, with ages between 2 and 18 years will be selected from Trakya University Faculty of Medicine Pediatric Oncology outpatient polyclinic and clinic and Physical Therapy and Rehabilitation polyclinic and clinic.

You may qualify if:

• Be between the ages of 2-18 years
• Being under pediatric oncology outpatient/clinical follow-up
• Being able to stand unaided without using a cane/walker

You may not qualify if:

• Having any of the diagnoses of hypertension, any cardiac arrhythmia-conduction disorders, coronary artery disease, heart failure, diabetes mellitus, hyperlipidemia, cardiovascular diseases, COPD, pulmonary infection, active infection.
• Depression Illness that causes balance problems
• Peripheral vascular disease
• Presence of disease that prevents standing up with support.
• Presence of diseases that may cause muscle mass loss (cerebral palsy, neuromuscular disease, congenital metabolic disorder, brain damage) mental retardation
• Children with a severe emotional disorder, adjustment disorder
• Physical disability to prevent safe and appropriate testing
• Having used anti-flu medicine in the last 1 week
• Failure to obtain consent.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (13)

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• Fernandez-Pineda I, Hudson MM, Pappo AS, Bishop MW, Klosky JL, Brinkman TM, Srivastava DK, Neel MD, Rao BN, Davidoff AM, Krull KR, Mulrooney DA, Robison LL, Ness KK. Long-term functional outcomes and quality of life in adult survivors of childhood extremity sarcomas: a report from the St. Jude Lifetime Cohort Study. J Cancer Surviv. 2017 Feb;11(1):1-12. doi: 10.1007/s11764-016-0556-1. Epub 2016 Jun 4.

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• Ooi PH, Thompson-Hodgetts S, Pritchard-Wiart L, Gilmour SM, Mager DR. Pediatric Sarcopenia: A Paradigm in the Overall Definition of Malnutrition in Children? JPEN J Parenter Enteral Nutr. 2020 Mar;44(3):407-418. doi: 10.1002/jpen.1681. Epub 2019 Jul 22.

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• Phillips SM, Padgett LS, Leisenring WM, Stratton KK, Bishop K, Krull KR, Alfano CM, Gibson TM, de Moor JS, Hartigan DB, Armstrong GT, Robison LL, Rowland JH, Oeffinger KC, Mariotto AB. Survivors of childhood cancer in the United States: prevalence and burden of morbidity. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):653-63. doi: 10.1158/1055-9965.EPI-14-1418.

  PMID: 25834148 BACKGROUND

• Ehrhardt MJ, Sandlund JT, Zhang N, Liu W, Ness KK, Bhakta N, Chemaitilly W, Krull KR, Brinkman TM, Crom DB, Kun L, Kaste SC, Armstrong GT, Green DM, Srivastava K, Robison LL, Hudson MM, Mulrooney DA. Late outcomes of adult survivors of childhood non-Hodgkin lymphoma: A report from the St. Jude Lifetime Cohort Study. Pediatr Blood Cancer. 2017 Jun;64(6):10.1002/pbc.26338. doi: 10.1002/pbc.26338. Epub 2016 Nov 15.

  PMID: 27860222 BACKGROUND

• Kesting SV, Gotte M, Seidel CC, Rosenbaum D, Boos J. Motor Performance After Treatment for Pediatric Bone Tumors. J Pediatr Hematol Oncol. 2015 Oct;37(7):509-14. doi: 10.1097/MPH.0000000000000396.

  PMID: 26207777 BACKGROUND

• Hudson MM, Oeffinger KC, Jones K, Brinkman TM, Krull KR, Mulrooney DA, Mertens A, Castellino SM, Casillas J, Gurney JG, Nathan PC, Leisenring W, Robison LL, Ness KK. Age-dependent changes in health status in the Childhood Cancer Survivor cohort. J Clin Oncol. 2015 Feb 10;33(5):479-91. doi: 10.1200/JCO.2014.57.4863. Epub 2014 Dec 29.

  PMID: 25547510 BACKGROUND

• Ness KK, DeLany JP, Kaste SC, Mulrooney DA, Pui CH, Chemaitilly W, Karlage RE, Lanctot JQ, Howell CR, Lu L, Srivastava DK, Robison LL, Hudson MM. Energy balance and fitness in adult survivors of childhood acute lymphoblastic leukemia. Blood. 2015 May 28;125(22):3411-9. doi: 10.1182/blood-2015-01-621680. Epub 2015 Mar 26.

  PMID: 25814529 BACKGROUND

• Borges TC, Gomes TLN, Pimentel GD. Sarcopenia as a predictor of nutritional status and comorbidities in hospitalized patients with cancer: A cross-sectional study. Nutrition. 2020 May;73:110703. doi: 10.1016/j.nut.2019.110703. Epub 2019 Dec 14.

  PMID: 32007693 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

• Mijnarends DM, Koster A, Schols JM, Meijers JM, Halfens RJ, Gudnason V, Eiriksdottir G, Siggeirsdottir K, Sigurdsson S, Jonsson PV, Meirelles O, Harris T. Physical activity and incidence of sarcopenia: the population-based AGES-Reykjavik Study. Age Ageing. 2016 Sep;45(5):614-20. doi: 10.1093/ageing/afw090. Epub 2016 May 17.

  PMID: 27189729 BACKGROUND

• Yip C, Dinkel C, Mahajan A, Siddique M, Cook GJ, Goh V. Imaging body composition in cancer patients: visceral obesity, sarcopenia and sarcopenic obesity may impact on clinical outcome. Insights Imaging. 2015 Aug;6(4):489-97. doi: 10.1007/s13244-015-0414-0. Epub 2015 Jun 13.

  PMID: 26070723 BACKGROUND

• Joffe L, Schadler KL, Shen W, Ladas EJ. Body Composition in Pediatric Solid Tumors: State of the Science and Future Directions. J Natl Cancer Inst Monogr. 2019 Sep 1;2019(54):144-148. doi: 10.1093/jncimonographs/lgz018.

  PMID: 31532526 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Neoplasms; Internet Addiction Disorder; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Technology Addiction; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 24, 2022
• Study Start: October 4, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)