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| Name | Class |
|---|---|
| Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany | OTHER |
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Soft tissue and bone sarcomas of the lower extremity pose significant challenges for affected individuals, often associated with considerable burden. Chemotherapy, load restrictions, and surgery frequently result in long-term physical limitations, causing structural and functional deterioration. These challenges are particularly pronounced in childhood and adolescence, as they affect physiological development, resilience, and autonomy. Yet, it remains unclear whether these deficits can be fully compensated after treatment or if they result in long-term limitations, as this has not been sufficiently studied.
This bicentric study includes children and adolescents undergoing follow-up care for soft tissue or bone sarcoma of the lower extremity within 1 to 5 years since end of therapy. The cohort did not receive any specific prehabilitative training during neoadjuvant therapy. Participants will be divided into two subgroups based on the study site: (1) participants who participated in a non-specific exercise program during acute therapy and (2) participants who did not receive any exercise promotion during acute therapy. Target sample size is n=16. The study has been consented by the local ethics committee.
Several structural and functional parameters are measured to document the natural status of muscular structures and functional abilities after the treatment of a solid tumor in the lower extremities, with a focus on identifying specific deficits and the associated long-term limitations in daily life. The measurements include psoas muscle area, body composition, strength, mobility, balance ability, gait analysis, two questionnaires on physical activity and quality of life, and quantitative measures of the clinical course during acute treatment (days of hospitalization, infection rates, etc.).
For children and adolescents, daily functionality and the experience of autonomy are crucial for physiological development and contribute significantly to quality of life. Therefore, these factors should be investigated and supported in this cohort, a group that is currently underrepresented in scientific research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survivors of childhood bone or soft tissue sarcomas of the lower extremity | Survivors aged 6-18 years who were treated for bone or soft tissue sarcoma of the lower extremity in one of the recruiting study sites, 1-5 years following the end of therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Total psoas muscle area | Total psoas muscle area at lumbal level (L4) analyzed via MRI or PET CT | At diagnostic procedure 1-5 years following the end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Fat-free mass | The weight of all body components excluding fat, measured in kilograms, using bioimpedance analysis. Outcome measures 2.-6. will be combined to report body composition. | At diagnostic procedure 1-5 years following the end of therapy |
| Fat mass |
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Inclusion Criteria:
Exclusion Criteria:
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Participants include children and adolescents during follow-up in Munich/Germany for soft tissue sarcoma or bone tumor at the lower extremity currently 1-5 years after cessation of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Sabine V Kesting, Dr. rer. medic. | Technical University of Munich | Principal Investigator |
| Irene von-Luettichau, Prof. Dr. med. | Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. von Haunersches Kinderspital, University of Munich | Munich | Bavaria | 80337 | Germany | ||
| Technical University of Munich, Germany; TUM School of Medicine and Health, Department of Pediatrics. German Center for Child and Adolescent Health (DZKJ), partner site Munich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36290890 | Background | Basteck S, Guder WK, Dirksen U, Krombholz A, Streitburger A, Reinhardt D, Gotte M. Effects of an Exercise Intervention on Gait Function in Young Survivors of Osteosarcoma with Megaendoprosthesis of the Lower Extremity-Results from the Pilot Randomized Controlled Trial proGAIT. Curr Oncol. 2022 Oct 14;29(10):7754-7767. doi: 10.3390/curroncol29100613. | |
| 32483740 |
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Total body fat weight, measured in kilograms, assessed via bioimpedance analysis. Outcome measures 2.-6. will be combined to report body composition. |
| At diagnostic procedure 1-5 years following the end of therapy |
| Total body water | The proportion of total body water in kg, expressed as percentage, measured through bioimpedance analysis. Outcome measures 2.-6. will be combined to report body composition. | At diagnostic procedure 1-5 years following the end of therapy |
| Body cell mass | The mass of metabolically active cells in the body, measured in kilograms, via bioimpedance analysis. Outcome measures 2.-6. will be combined to report body composition. | At diagnostic procedure 1-5 years following the end of therapy |
| Phase angle | An indicator of cellular health and membrane integrity, measured in degrees using bioimpedance analysis. Outcome measures 2.-6. will be combined to report body composition. | At diagnostic procedure 1-5 years following the end of therapy |
| Muscle strength | Overall muscle strength measured by hand-grip dynamometry. | At diagnostic procedure, 1-5 years following the end of therapy |
| Range of motion of the adjacent joints | Range of motion of the adjacent joints measured with an analog goniometer. | At diagnostic procedure, 1-5 years following the end of therapy |
| Gait analysis | Gait analysis measured with a force plate to analyze how pressure is distributed during stance phases of walking (vertical ground reaction force during loading response, mid stance, terminal stance, toe off). | At diagnostic procedure, 1-5 years following the end of therapy |
| Path length | The total distance traveled by the center of pressure during balance assessment, measured in centimeters using a force plate. Outcome measures 10.-13. will be combined to report balance ability. | At diagnostic procedure 1-5 years following the end of therapy |
| Mean velocity | The average speed of center of pressure shifts during balance assessment, measured in meters per second with a force plate. Outcome measures 10.-13. will be combined to report balance ability. | At diagnostic procedure 1-5 years following the end of therapy |
| Sway angle | The angular deviation of the center of pressure from a neutral position during balance tasks, measured in degrees using a force plate. Outcome measures 10.-13. will be combined to report balance ability. | At diagnostic procedure 1-5 years following the end of therapy |
| Equlibrium score | Calculated from the anterior-posterior and medial-lateral projection of the 90% Standard Ellipse and estimated height of center of gravity during balance tasks in percentage using a force plate. Outcome measures 10.-13. will be combined to report balance ability. | At diagnostic procedure 1-5 years following the end of therapy |
| Level of physical activity | Level of physical activity following therapy measured with the standardized ActiOn questionnaire | At diagnostic procedure, 1-5 years following the end of therapy |
| Quality of life | Quality of life during and following therapy measured with the standardized and validated KINDL questionnaire | At diagnostic procedure, 1-5 years following the end of therapy |
| Munich |
| Bavaria |
| 80804 |
| Germany |
| Bhagat A, Kleinerman ES. Anthracycline-Induced Cardiotoxicity: Causes, Mechanisms, and Prevention. Adv Exp Med Biol. 2020;1257:181-192. doi: 10.1007/978-3-030-43032-0_15. |
| 37052966 | Background | Ehrhardt MJ, Leerink JM, Mulder RL, Mavinkurve-Groothuis A, Kok W, Nohria A, Nathan PC, Merkx R, de Baat E, Asogwa OA, Skinner R, Wallace H, Lieke Feijen EAM, de Ville de Goyet M, Prasad M, Bardi E, Pavasovic V, van der Pal H, Fresneau B, Demoor-Goldschmidt C, Hennewig U, Steinberger J, Plummer C, Chen MH, Teske AJ, Haddy N, van Dalen EC, Constine LS, Chow EJ, Levitt G, Hudson MM, Kremer LCM, Armenian SH. Systematic review and updated recommendations for cardiomyopathy surveillance for survivors of childhood, adolescent, and young adult cancer from the International Late Effects of Childhood Cancer Guideline Harmonization Group. Lancet Oncol. 2023 Mar;24(3):e108-e120. doi: 10.1016/S1470-2045(23)00012-8. Epub 2023 Feb 14. |
| 27836415 | Background | Furtado S, Errington L, Godfrey A, Rochester L, Gerrand C. Objective clinical measurement of physical functioning after treatment for lower extremity sarcoma - A systematic review. Eur J Surg Oncol. 2017 Jun;43(6):968-993. doi: 10.1016/j.ejso.2016.10.002. Epub 2016 Oct 14. |
| 32483741 | Background | Garcia MB, Ness KK, Schadler KL. Exercise and Physical Activity in Patients with Osteosarcoma and Survivors. Adv Exp Med Biol. 2020;1257:193-207. doi: 10.1007/978-3-030-43032-0_16. |
| 34490156 | Background | Gauss G, Beller R, Boos J, Daggelmann J, Stalf H, Wiskemann J, Gotte M. Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Front Pediatr. 2021 Aug 19;9:682496. doi: 10.3389/fped.2021.682496. eCollection 2021. |
| 36073842 | Background | Gotte M, Gauss G, Dirksen U, Driever PH, Basu O, Baumann FT, Wiskemann J, Boos J, Kesting SV. Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. Pediatr Blood Cancer. 2022 Nov;69(11):e29953. doi: 10.1002/pbc.29953. Epub 2022 Sep 8. |
| 31920002 | Background | Lurz E, Patel H, Lebovic G, Quammie C, Woolfson JP, Perez M, Ricciuto A, Wales PW, Kamath BM, Chavhan GB, Juni P, Ng VL. Paediatric reference values for total psoas muscle area. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):405-414. doi: 10.1002/jcsm.12514. Epub 2020 Jan 9. |
| 36458382 | Background | Pilz F, Vill K, Rawer R, Bonfert M, Tacke M, Heussinger N, Muller-Felber W, Blaschek A. Mechanography in children: pediatric references in postural control. J Musculoskelet Neuronal Interact. 2022 Dec 1;22(4):431-454. |
| 35931609 | Background | Runco DV, Zimmers TA, Bonetto A. The urgent need to improve childhood cancer cachexia. Trends Cancer. 2022 Dec;8(12):976-979. doi: 10.1016/j.trecan.2022.07.005. Epub 2022 Aug 3. |
| 23292667 | Background | Winter CC, Muller C, Hardes J, Gosheger G, Boos J, Rosenbaum D. The effect of individualized exercise interventions during treatment in pediatric patients with a malignant bone tumor. Support Care Cancer. 2013 Jun;21(6):1629-36. doi: 10.1007/s00520-012-1707-1. Epub 2013 Jan 5. |
| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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