NCT06737172

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

Cross-sectional Analysis of Functional and Structural Outcomes in Children, Adolescents and Young Adults Within Follow-up of Bone or Soft Tissue Sarcomas of the Lower Extremity

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 18 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-10-31
• Completion: 2027-03-31
• First posted: 2024-12-17
• Last updated: 2025-05-28

Locations

2 sites across 1 country: Germany