By InvitationNot Applicable

Prehabilitation in Childhood Soft Tissue or Bone Sarcomas

Germany16 participantsStarted 2025-02-20

Plain-language 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.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility Criteria 1 - Recruitment Rate

Timeframe: At enrollment

Feasibility Criteria 2 - Acceptance

Timeframe: From enrollment to 12 months following end of therapy

Feasibility Criteria 3 - Data Quality

Timeframe: From enrollment to 12 months following end of therapy

Feasibility Criteria 4 - Practicability

Timeframe: From enrollment to 12 months following end of therapy

Feasibility Criteria 5 - Participants' Feedback

Timeframe: From enrollment to 12 months following end of therapy

Trial details

NCT IDNCT06743958

SponsorTechnical University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-30

View on ClinicalTrials.gov More Soft Tissue Sarcoma of the Lower Extremity trials

Plain-language summary

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility Criteria 1 - Recruitment Rate

Timeframe: At enrollment

Feasibility Criteria 2 - Acceptance

Timeframe: From enrollment to 12 months following end of therapy

Feasibility Criteria 3 - Data Quality

Timeframe: From enrollment to 12 months following end of therapy

Feasibility Criteria 4 - Practicability

Timeframe: From enrollment to 12 months following end of therapy

Feasibility Criteria 5 - Participants' Feedback

Timeframe: From enrollment to 12 months following end of therapy