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Clinical Trials in Germany / NCT06737172
Active, not recruiting Observational

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

NCT06737172 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2025-04-01
Last updated
2026-08-18

Condition(s) studied

Soft Tissue Sarcoma of the Lower ExtremityBone Sarcoma of the Lower ExtremityChildhood and Adolescent Cancer

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Dr. von Haunersches Kinderspital, University of Munich Munich Bavaria
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

More Technical University of Munich trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06737172 on ClinicalTrials.gov ↗ ← All trials in Germany