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

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

• Registration Number: NCT06737172
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-17
• Study Start: 2025-04-01
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-10-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total psoas muscle area	At diagnostic procedure 1-5 years following the end of therapy	Total psoas muscle area at lumbal level (L4) analyzed via MRI or PET CT

Secondary Outcome Measures

Name	Time	Method
Fat-free mass	At diagnostic procedure 1-5 years following the end of therapy	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.
Fat mass	At diagnostic procedure 1-5 years following the end of therapy	Total body fat weight, measured in kilograms, assessed via bioimpedance analysis.; Outcome measures 2.-6. will be combined to report body composition.
Total body water	At diagnostic procedure 1-5 years following the end of therapy	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.
Body cell mass	At diagnostic procedure 1-5 years following the end of therapy	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.
Phase angle	At diagnostic procedure 1-5 years following the end of therapy	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.
Muscle strength	At diagnostic procedure, 1-5 years following the end of therapy	Overall muscle strength measured by hand-grip dynamometry.
Range of motion of the adjacent joints	At diagnostic procedure, 1-5 years following the end of therapy	Range of motion of the adjacent joints measured with an analog goniometer.
Gait analysis	At diagnostic procedure, 1-5 years following the end of therapy	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).
Path length	At diagnostic procedure 1-5 years following the end of therapy	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.
Mean velocity	At diagnostic procedure 1-5 years following the end of therapy	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.
Sway angle	At diagnostic procedure 1-5 years following the end of therapy	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.
Equlibrium score	At diagnostic procedure 1-5 years following the end of therapy	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.
Level of physical activity	At diagnostic procedure, 1-5 years following the end of therapy	Level of physical activity following therapy measured with the standardized ActiOn questionnaire
Quality of life	At diagnostic procedure, 1-5 years following the end of therapy	Quality of life during and following therapy measured with the standardized and validated KINDL questionnaire

Trial Locations

Locations (2)

Dr. von Haunersches Kinderspital, University of Munich; 🇩🇪 Munich, Bavaria, 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; 🇩🇪 Munich, Bavaria, Germany