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NCT Number: NCT06737172

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

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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Key information

Conditions

Soft Tissue Sarcoma of the Lower Extremity Bone Diseases Bone Neoplasms Bone Sarcoma of the Lower Extremity Childhood and Adolescent Cancer Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Sarcoma

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total psoas muscle area

    Time frame: 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 outcomes

  1. Fat-free mass

    Time frame: 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.

  2. Fat mass

    Time frame: 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.

  3. Total body water

    Time frame: 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.

  4. Body cell mass

    Time frame: 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.

  5. Phase angle

    Time frame: 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.

  6. Muscle strength

    Time frame: At diagnostic procedure, 1-5 years following the end of therapy

    Overall muscle strength measured by hand-grip dynamometry.

  7. Range of motion of the adjacent joints

    Time frame: At diagnostic procedure, 1-5 years following the end of therapy

    Range of motion of the adjacent joints measured with an analog goniometer.

  8. Gait analysis

    Time frame: 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).

  9. Path length

    Time frame: 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.

  10. Mean velocity

    Time frame: 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.

  11. Sway angle

    Time frame: 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.

  12. Equlibrium score

    Time frame: 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.

  13. Level of physical activity

    Time frame: At diagnostic procedure, 1-5 years following the end of therapy

    Level of physical activity following therapy measured with the standardized ActiOn questionnaire

  14. Quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany

Registry information

Official study title

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

Acronym: FOCUS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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