Bone Sarcoma of the Lower Extremity, Childhood and Adolescent Cancer, Soft Tissue Sarcoma of the Lower Extremity
Conditions
Keywords
bone tumor, soft tissue sarcoma, functional outcomes, cross-sectional analysis
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.
Interventions
None listed
Sponsors
Technical University of Munich
Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORSabine V Kesting, Dr. rer. medic.
Technical University of Munich
PRINCIPAL_INVESTIGATORIrene von-Luettichau, Prof. Dr. med.
Technical University of Munich
Outcome results
None listed