Functional and Structural Outcomes Following Childhood Bone or Soft Tissue Sarcomas of the Lower Extremity

NCT06737172 | Enrolling By Invitation

• 1 other identifier: FOCUS
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Soft Tissue Sarcoma of the Lower Extremity; Bone Sarcoma of the Lower Extremity; Childhood and Adolescent Cancer

Keywords

bone tumor; soft tissue sarcoma; functional outcomes; cross-sectional analysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Fat-free mass

  At diagnostic procedure 1-5 years following the end of therapy

• Fat mass

  At diagnostic procedure 1-5 years following the end of therapy

• Total body water

  At diagnostic procedure 1-5 years following the end of therapy

• Body cell mass

  At diagnostic procedure 1-5 years following the end of therapy

• Phase angle

  At diagnostic procedure 1-5 years following the end of therapy

Study Arms (1)

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Cessation of treatment for a bone tumor or soft tissue sarcoma of the lower extremity 1-5 years ago
• Age Range of 6 to 18 years
• Treatment has been conducted at one of the two designated study sites

You may not qualify if:

• Medical contraindications for testing (e.g. injury, pain, dizziness, lack of orthopedic clearance for weight-bearing in the tumor region, other acute orthopedic limitations unrelated to the underlying condition, etc.)
• Language barriers that prevent understanding of the instructions for study participation
• Cognitive impairment or developmental delay that hinders comprehension of the instructions in the testing situation, thereby preventing standardized diagnostic data collection

Sponsors & Collaborators

• Technical University of Munich: lead
• Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany: collaborator

Study Sites (2)

Dr. von Haunersches Kinderspital, University of Munich

Munich, Bavaria, 80337, Germany

Location

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

Munich, Bavaria, 80804, Germany

Location

Related Publications (11)

• 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.

  PMID: 36290890 BACKGROUND

• 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.

  PMID: 32483740 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.

  PMID: 37052966 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.

  PMID: 27836415 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.

  PMID: 32483741 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.

  PMID: 34490156 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.

  PMID: 36073842 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.

  PMID: 31920002 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.

  PMID: 36458382 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.

  PMID: 35931609 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.

  PMID: 23292667 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Officials

• Sabine V Kesting, Dr. rer. medic.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

• Irene von-Luettichau, Prof. Dr. med.

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Exercise Oncology Working Group

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 17, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 28, 2025

Record last verified: 2024-11

Locations

DE (2)