Clinical trial NCT06743958: Prehabilitation in Childhood Soft Tissue or Bone Sarcomas
Official title: Prehabilitative Training in Children and Adolescents With Soft Tissue or Bone Sarcoma of the Lower Extremity - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Soft Tissue Sarcoma of the Lower Extremity
Bone Tumor of the Lower Extremity
Childhood and Adolescent Cancer
Keywords: prehabilitation
bone tumor
soft tissue sarcoma
exercise intervention
childhood cancer
functional outcomes
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany
First posted: 2024-12-20
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bicentric feasibility trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the feasibility of a prehabilitative training intervention. The intervention includes specific strength and balance exercises during neoadjuvant chemotherapy with children and adolescents diagnosed with soft tissue or bone tumor in the lower extremity. This explorative approach of prehabilitation might help to reduce muscle and bone weakening and associated functional limitations during and after acute therapy. By designing this study like a controlled clinical trials, the investigators will also gather preliminary data on the intervention's potential effects in enhancing/on the pre-operative condition. The goal is to improve post-operative outcome and rehabilitation processes in children and adolescents diagnosed with soft tissue or bone sarcoma of the lower extremity.

Detailed description: 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. In childhood and adolescence, these challenges are particularly pronounced, as they affect physiological development, resilience, and autonomy. Although movement promotion and therapeutic programs are designed to address these deficits, they are typically implemented post-operatively and during follow-up care. The benefit of implementing a specific program before the operative therapy remains elusive. The presented study explores the feasibility of a supervised prehabilitative training intervention and gather preliminary data on its potential effects in enhancing the pre-operative condition. The goal is to improve post-operative outcome and rehabilitation in children and adolescents diagnosed with soft tissue or bone sarcoma of the lower extremity.

This bicentric feasibility study, designed as a controlled clinical trial, enrolls all children and adolescents aged 6-18 years who are newly diagnosed with primary osteosarcoma, Ewing's sarcoma, or rhabdomyosarcoma of the lower extremity. Based on the study site, participants are allocated to either the intervention group (IG) or control group (CG), with a target sample size of 16-18. The intervention consists of specific strength and balance training sessions during neoadjuvant therapy, conducted at least twice a week for a minimum of 30 minutes per session. The CG does not receive any training intervention. The study has been consented by the local ethics committee.

The primary endpoint is the proof of feasibility of the intervention, assessed via descriptive analysis of recruitment rate, acceptance, data quality, practicability, and safety (adverse events). The secondary endpoint is the demonstration of the efficacy of the intervention comparing structural and functional measurements intra-individually and between groups at four timepoints: within ten days post-diagnosis, pre-operatively (post-intervention), at the end of therapy, and at 1-year follow-up. 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 treatment (days of hospitalization, infection rates, etc.).

This study is designed to evaluate the feasibility of a specific prehabilitative training intervention in children and adolescents with soft tissue or bone sarcoma of the lower extremity. Additionally, preliminary data on the effects of this training are collected, aiming to mitigate muscle mass loss, support physiological body composition, and improve functional outcomes such as balance, gait, and physical activity. Enhancing everyday functionality and fostering a sense of autonomy can significantly improve the quality of life in this population, underscoring the importance of investigating and promoting such interventions in this underrepresented patient group.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a bone tumor or soft tissue sarcoma of the lower extremity
* Diagnosed less than 10 days ago, confirmed through biopsy
* Age Range of 6 to 18 years
* Treatment will be conducted at one of the two designated study sites

Exclusion Criteria:

* Medical contraindications for the implementation of the intervention and measurements, in consultation with the treating physicians (e.g., acute risk of bleeding or fractures, pain, infection, nausea, 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 and intervention

Primary outcomes:
measure: Feasibility Criteria 1 - Recruitment Rate
timeFrame: At enrollment
measure: Feasibility Criteria 2 - Acceptance
timeFrame: From enrollment to 12 months following end of therapy
measure: Feasibility Criteria 3 - Data Quality
timeFrame: From enrollment to 12 months following end of therapy
measure: Feasibility Criteria 4 - Practicability
timeFrame: From enrollment to 12 months following end of therapy
measure: Feasibility Criteria 5 - Participants' Feedback
timeFrame: From enrollment to 12 months following end of therapy
Secondary outcomes:
measure: Total psoas muscle area
timeFrame: From enrollment to 12 months following end of therapy
measure: Fat-free mass
timeFrame: From enrollment to 12 months following end of therapy
measure: Fat mass
timeFrame: From enrollment to 12 months after end of therapy
measure: Total body water
timeFrame: From enrollment to 12 months after end of therapy
measure: Body cell mass
timeFrame: From enrollment to 12 months after end of therapy
measure: Phase angle
timeFrame: From enrollment to 12 months after end of therapy
measure: Muscle strength
timeFrame: From enrollment to 12 months following end of therapy.
measure: Range of motion of the adjacent joints
timeFrame: From enrollment to 12 months following end of therapy
measure: Gait analysis
timeFrame: From enrollment to 12 months following end of therapy
measure: Path length
timeFrame: From enrollment to 12 months after end of therapy
measure: Mean velocity
timeFrame: From enrollment to 12 months after end of therapy
measure: Sway angle
timeFrame: From enrollment to 12 months after end of therapy
measure: Equlibrium score
timeFrame: From enrollment to 12 months after end of therapy
measure: Level of physical activity
timeFrame: From enrollment to 12 months following end of therapy
measure: Quality of life
timeFrame: From enrollment to 12 months following end of therapy
measure: Quantitative measures of clinical course during treatment
timeFrame: From enrollment to 12 months following end of therapy
Other outcomes:
Locations:
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
city: Munich
country: Germany
facility: Dr. von Haunersches Kinderspital
Study officials:
References:
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