SarcopeniaNCT05294380
Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients
An observational study of Sarcopenia and Pediatric Cancer, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Pediatric Cancer
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2021to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Physical disability to prevent safe and appropriate testing
- Having used anti-flu medicine in the last 1 week
- Failure to obtain consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Medical Faculty
Edirne, 22030
About this study
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.
Read more
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.
Read the detailed description
As incidence and survival, rates increase in childhood and adolescent cancers, the importance of rehabilitation in this area increases (1-5). Functional limitations in the physical and cognitive domains are reported by children throughout the continuum of cancer care. These limitations are also experienced in very young children under 4 years of age with leukemia and lymphoma, adolescents and young adults struggling with leukemia, sarcoma, or central nervous system tumors (3, 6). Studies in adults who have won the childhood malignancy struggle report adulthood problems. Among these problems, deterioration of physical function, decrease in physical fitness, deterioration of neurocognition, fatigue, and pain, which affect their employment, participation in the life, and quality of life, are reported (2, 5, 7, 8). The roles of rehabilitation professionals, physical medicine and rehabilitation specialists, and physiotherapists in the childhood cancer population are particularly emphasized in the literature to prevent these limitations (1).
Malnutrition in children with chronic diseases is a common condition that causes problems in patient care. Sarcopenia or decreased musculoskeletal muscle mass contributes to the alteration of muscle function. This has been demonstrated in adults with chronic disease, but its impact on clinical outcomes in children has not been adequately described in the pediatric literature. Research in this area is affected by the lack of a uniform definition of sarcopenia in children. However, there is concern that childhood sarcopenia may have a long-term negative impact on growth, neurocognitive development, and quality of life-extending into adulthood. The similarities between sarcopenia and malnutrition are depleted lean muscle mass, changes in muscle function, and suboptimal food intake leading to nutritional deficiencies. In pediatric patients, this leads to growth failure and a potential neurodevelopmental delay in cognition, gross and fine motor development.
In children, both malnutrition and sarcopenia are associated with prolongation of hospital stay, increased morbidity, mortality, and health-related complications (3).
In adult oncological patients (over 18 years of age), the risk of sarcopenia, which is stated to predict malnutrition, is reported to be 40% (9).
As the investigators mentioned before, there is no single definition of sarcopenia with strict rules in childhood sarcopenia. However, in the 2019 European update, three criteria are emphasized in the diagnosis of sarcopenia for elderly individuals. These criteria are:
- decrease in muscle strength,
- decrease in muscle quantity or quality, and
- is stated as a decrease in physical performance. 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 same update raises "red flags" in screening for sarcopenia. These red flags include: general weakness, visual loss of muscle mass, decreased muscle strength of the arms or legs, slow walking speed, fatigue, falls, loss of weight, loss of energy, and difficulty performing activities of daily living (10). Therefore, current research aims to question these criteria and the existence of red flags in the pediatric population.
Whether a sedentary lifestyle or physical inactivity due to the disease contributes to the development of sarcopenia (11).
Smartphone addiction is suggested as one of the causes of physical inactivity. Therefore, our study, it is aimed to evaluate both situations.
Physical fitness is the ability to correctly and successfully perform occupational, recreational, and daily activities without fatigue.
It includes two main components: health-related physical fitness (body composition, cardiorespiratory endurance, muscle strength and endurance, flexibility) and performance-related physical fitness (balance, coordination, reaction time, agility, speed, and power). In the current study, pediatric oncology will be evaluated in both patient and control participants.
In future directions for body composition assessments in pediatric oncological cases, "determining the prevalence and clinical significance of sarcopenia and sarcopenic obesity, which are potentially modifiable risk factors, will improve current understanding of the patient's nutritional status, assist in the early identification of those at greatest risk for adverse outcomes, and assist clinicians in their treatment plans. It will enable them to optimize and improve their effects" (12). Further research in this area could lead to improving and customizing chemotherapy dose, optimizing the timing of nutritional and physiotherapy supportive care interventions, and increasing tolerance to both traditional and new treatments. Therefore, progress in this area may have a long-term impact on the patient's quality of life and successful transition to survival (13).
Purpose of the research:
It aims to answer the question of 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.
Benefits and contributions of the research to science and society:
In the light of the information obtained as a result of the research, a window of opportunity will be provided for the rehabilitation service for the prevention of possible complications that may develop based on the sarcopenia status and related factors in pediatric oncological children, and it is anticipated that this will benefit science and the society.
Current 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.
When the literature on the subject of our study was examined, in the study of Lurz et al., computed tomography images of children aged 0-18 were compared by reviewing healthy pediatric trauma victims. In this retrospective study, 23 patients and 46 healthy controls were included. Considering this study and since it was calculated that 26 patients from each group should be included in the power analysis, in our study where muscle strength, muscle quantity/quality, and physical performance parameters will be compared, 30 patients between the ages of 2-18 with and without the pediatric oncological disease (probable case It is planned to include the child (taking into account the losses of the child).
- Conditions
- Sarcopenia, Pediatric Cancer
- Keywords
- sarcopenia, Smartphone Addiction, Pediatric Cancer, Hematologic Malignancy, Anxiety Depression, bioelectrical impedance analysis
- Medical subject headings
- Sarcopenia, Neoplasms, Internet Addiction Disorder, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Seven months
Secondary outcomes (8)
Symptoms or signs of sarcopenia
"Red flags of sarcopenia" with a "family-oriented questionnaire"
Measured: Seven months
The presence of malnutrition
The presence of malnutrition will be evaluated with the Simple Pediatric Nutrition Screening questionnaire.
Measured: Seven months
Physical activity for parent
- Short Form International Physical Activity Questionnaire for Parent
Measured: Seven months
Physical activity for preschool children and school-age children and adolescents
- Physical activity for preschool children and school-age children and adolescents
Measured: Seven months
Physical activity for elementary 4-8th grades
- Physical activity scale (elementary 4-8th grades)
Measured: Seven months
Smartphone Addiction
Smartphone Addiction (Parent and Child Smartphone Addiction Scale Short Form). The cut-off point is 29.5 for the Smartphone Addiction Scale-Short Version. When the score is greater than 29.50, the participant is determined as smartphone-addicted.
Measured: Seven months
Childhood cancer fatigue
-Childhood cancer fatigue scale administered to mothers (• Child fatigue scale parent form (weekly)) The minimum and maximum scores are 17 and 85, respectively. An increase in score indicates an increase in fatigue.
Measured: Seven months
Depression status
Depression status will be assessed with the Hospital Anxiety and Depression (HAD) Scale. The cut-off point is 10 for the anxiety subscale and 7 for the depression subscale.
Measured: Seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start4 Oct 2021
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FİLİZ TUNA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294380
- Sponsor's protocol ID
- TÜTF-BAEK 2021/389
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanner L, Keppner K, Lesmeister D, Lyons K, Rock K, Sparrow J. Cancer Rehabilitation in the Pediatric and Adolescent/Young Adult Population. Semin Oncol Nurs. 2020 Feb;36(1):150984. doi: 10.1016/j.soncn.2019.150984. Epub 2020 Jan 24.
PubMed 31983485Fernandez-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.
PubMed 27262580Ooi 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.
PubMed 31328301Phillips 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.
PubMed 25834148Ehrhardt 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.
PubMed 27860222Kesting 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.
PubMed 26207777Hudson 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.
PubMed 25547510Ness 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.
PubMed 25814529Borges 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.
PubMed 32007693Cruz-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.
PubMed 30312372Mijnarends 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.
PubMed 27189729Yip 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.
PubMed 26070723Joffe 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.
PubMed 31532526
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients
- ClinicalTrials.gov ID
- NCT05294380
- Acronym / sponsor ID
- TÜTF-BAEK 2021/389
- Conditions
- Sarcopenia, Pediatric Cancer
- Keywords
- sarcopenia, Smartphone Addiction, Pediatric Cancer, Hematologic Malignancy, Anxiety Depression, bioelectrical impedance analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As incidence and survival, rates increase in childhood and adolescent cancers, the importance of rehabilitation in this area increases (1-5). Functional limitations in the physical and cognitive domains are reported by children throughout the continuum of cancer care. These limitations are also experienced in very young children under 4 years of age with leukemia and lymphoma, adolescents and young adults struggling with leukemia, sarcoma, or central nervous system tumors (3, 6). Studies in adults who have won the childhood malignancy struggle report adulthood problems. Among these problems, deterioration of physical function, decrease in physical fitness, deterioration of neurocognition, fatigue, and pain, which affect their employment, participation in the life, and quality of life, are reported (2, 5, 7, 8). The roles of rehabilitation professionals, physical medicine and rehabilitation specialists, and physiotherapists in the childhood cancer population are particularly emphasized in the literature to prevent these limitations (1).
Malnutrition in children with chronic diseases is a common condition that causes problems in patient care. Sarcopenia or decreased musculoskeletal muscle mass contributes to the alteration of muscle function. This has been demonstrated in adults with chronic disease, but its impact on clinical outcomes in children has not been adequately described in the pediatric literature. Research in this area is affected by the lack of a uniform definition of sarcopenia in children. However, there is concern that childhood sarcopenia may have a long-term negative impact on growth, neurocognitive development, and quality of life-extending into adulthood. The similarities between sarcopenia and malnutrition are depleted lean muscle mass, changes in muscle function, and suboptimal food intake leading to nutritional deficiencies. In pediatric patients, this leads to growth failure and a potential neurodevelopmental delay in cognition, gross and fine motor development.
In children, both malnutrition and sarcopenia are associated with prolongation of hospital stay, increased morbidity, mortality, and health-related complications (3).
In adult oncological patients (over 18 years of age), the risk of sarcopenia, which is stated to predict malnutrition, is reported to be 40% (9).
As the investigators mentioned before, there is no single definition of sarcopenia with strict rules in childhood sarcopenia. However, in the 2019 European update, three criteria are emphasized in the diagnosis of sarcopenia for elderly individuals. These criteria are:
- decrease in muscle strength,
- decrease in muscle quantity or quality, and
- is stated as a decrease in physical performance. 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 same update raises "red flags" in screening for sarcopenia. These red flags include: general weakness, visual loss of muscle mass, decreased muscle strength of the arms or legs, slow walking speed, fatigue, falls, loss of weight, loss of energy, and difficulty performing activities of daily living (10). Therefore, current research aims to question these criteria and the existence of red flags in the pediatric population.
Whether a sedentary lifestyle or physical inactivity due to the disease contributes to the development of sarcopenia (11).
Smartphone addiction is suggested as one of the causes of physical inactivity. Therefore, our study, it is aimed to evaluate both situations.
Physical fitness is the ability to correctly and successfully perform occupational, recreational, and daily activities without fatigue.
It includes two main components: health-related physical fitness (body composition, cardiorespiratory endurance, muscle strength and endurance, flexibility) and performance-related physical fitness (balance, coordination, reaction time, agility, speed, and power). In the current study, pediatric oncology will be evaluated in both patient and control participants.
In future directions for body composition assessments in pediatric oncological cases, "determining the prevalence and clinical significance of sarcopenia and sarcopenic obesity, which are potentially modifiable risk factors, will improve current understanding of the patient's nutritional status, assist in the early identification of those at greatest risk for adverse outcomes, and assist clinicians in their treatment plans. It will enable them to optimize and improve their effects" (12). Further research in this area could lead to improving and customizing chemotherapy dose, optimizing the timing of nutritional and physiotherapy supportive care interventions, and increasing tolerance to both traditional and new treatments. Therefore, progress in this area may have a long-term impact on the patient's quality of life and successful transition to survival (13).
Purpose of the research:
It aims to answer the question of 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.
Benefits and contributions of the research to science and society:
In the light of the information obtained as a result of the research, a window of opportunity will be provided for the rehabilitation service for the prevention of possible complications that may develop based on the sarcopenia status and related factors in pediatric oncological children, and it is anticipated that this will benefit science and the society.
Current 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.
When the literature on the subject of our study was examined, in the study of Lurz et al., computed tomography images of children aged 0-18 were compared by reviewing healthy pediatric trauma victims. In this retrospective study, 23 patients and 46 healthy controls were included. Considering this study and since it was calculated that 26 patients from each group should be included in the power analysis, in our study where muscle strength, muscle quantity/quality, and physical performance parameters will be compared, 30 patients between the ages of 2-18 with and without the pediatric oncological disease (probable case It is planned to include the child (taking into account the losses of the child).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle quantity.
Time frame: Seven months
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.
Physical performance
Time frame: Seven months
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.
Muscle strength.
Time frame: Seven months
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.
8 secondary outcomes
Symptoms or signs of sarcopenia
Time frame: Seven months
The presence of malnutrition
Time frame: Seven months
Physical activity for parent
Time frame: Seven months
Physical activity for preschool children and school-age children and adolescents
Time frame: Seven months
Physical activity for elementary 4-8th grades
Time frame: Seven months
Smartphone Addiction
Time frame: Seven months
Childhood cancer fatigue
Time frame: Seven months
Depression status
Time frame: Seven months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 31983485Tanner L, Keppner K, Lesmeister D, Lyons K, Rock K, Sparrow J. Cancer Rehabilitation in the Pediatric and Adolescent/Young Adult Population. Semin Oncol Nurs. 2020 Feb;36(1):150984. doi: 10.1016/j.soncn.2019.150984. Epub 2020 Jan 24.
- Background: PubMed 27262580Fernandez-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.
- Background: PubMed 31328301Ooi 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.
- Background: PubMed 25834148Phillips 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.
- Background: PubMed 27860222Ehrhardt 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.
- Background: PubMed 26207777Kesting 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.
- Background: PubMed 25547510Hudson 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.
- Background: PubMed 25814529Ness 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.
- Background: PubMed 32007693Borges 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.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 27189729Mijnarends 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.
- Background: PubMed 26070723Yip 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Pediatric Cancer, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle quantity. (time frame: Seven months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294380, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.