Clinical trial NCT06737172: Functional and Structural Outcomes Following Childhood Bone or Soft Tissue Sarcomas of the Lower Extremity
Official 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Soft Tissue Sarcoma of the Lower Extremity
Bone Sarcoma of the Lower Extremity
Childhood and Adolescent Cancer
Keywords: bone tumor
soft tissue sarcoma
functional outcomes
cross-sectional analysis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
First posted: 2024-12-17
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants include children and adolescents during follow-up in Munich/Germany for soft tissue sarcoma or bone tumor at the lower extremity currently 1-5 years after cessation of treatment.

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.


Eligibility criteria: 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 outcomes:
measure: Total psoas muscle area
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
Secondary outcomes:
measure: Fat-free mass
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Fat mass
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Total body water
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Body cell mass
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Phase angle
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Muscle strength
timeFrame: At diagnostic procedure, 1-5 years following the end of therapy
measure: Range of motion of the adjacent joints
timeFrame: At diagnostic procedure, 1-5 years following the end of therapy
measure: Gait analysis
timeFrame: At diagnostic procedure, 1-5 years following the end of therapy
measure: Path length
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Mean velocity
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Sway angle
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Equlibrium score
timeFrame: At diagnostic procedure 1-5 years following the end of therapy
measure: Level of physical activity
timeFrame: At diagnostic procedure, 1-5 years following the end of therapy
measure: Quality of life
timeFrame: At diagnostic procedure, 1-5 years following the end of therapy
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dr. von Haunersches Kinderspital, University of Munich
state: Bavaria
city: Munich
country: Germany
facility: 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
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Sabine V Kesting, Dr. rer. medic.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Irene von-Luettichau, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
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