Prehabilitation in Childhood Soft Tissue or Bone Sarcomas

NCT06743958 | Enrolling By Invitation

• 1 other identifier: Prehab4Kids
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (5)

• Feasibility Criteria 1 - Recruitment Rate

  The number of children and adolescents diagnosed with bone and soft tissue sarcoma of the lower extremity who agree to participate compared to the total number approached for this study.

  At enrollment

• Feasibility Criteria 2 - Acceptance

  Number of performed exercise sessions during intervention period compared to intended sessions and number of performed measurements and compared to intended measurements.

  From enrollment to 12 months following end of therapy

• Feasibility Criteria 3 - Data Quality

  Number of evaluable exercise documentation data and measurement data.

  From enrollment to 12 months following end of therapy

• Feasibility Criteria 4 - Practicability

  Difference between scheduled and required time frame for the exercise sessions and measurements.

  From enrollment to 12 months following end of therapy

• Feasibility Criteria 5 - Participants' Feedback

  Feedback questionnaire with multiple choice options and free text answers.

  From enrollment to 12 months following end of therapy

Secondary Outcomes (16)

• Total psoas muscle area

  From enrollment to 12 months following end of therapy

• Fat-free mass

  From enrollment to 12 months following end of therapy

• Fat mass

  From enrollment to 12 months after end of therapy

• Total body water

  From enrollment to 12 months after end of therapy

• Body cell mass

  From enrollment to 12 months after end of therapy

Study Arms (2)

Intervention group

EXPERIMENTAL

Specific strength and balance training during neoadjuvant chemotherapy

Other: Exercise intervention

Control group

NO INTERVENTION

Interventions

Exercise intervention OTHER

Specific strength and balance training intervention during neoadjuvant chemotherapy, twice per week for 30 min, progression according to individual status

Intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany: collaborator

Study Sites (2)

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

Munich, Bavaria, 80804, Germany

Location

Dr. von Haunersches Kinderspital

Munich, 80337, Germany

Location

Related Publications (11)

• Winter CC, Muller C, Hardes J, Gosheger G, Boos J, Rosenbaum D. The effect of individualized exercise interventions during treatment in pediatric patients with a malignant bone tumor. Support Care Cancer. 2013 Jun;21(6):1629-36. doi: 10.1007/s00520-012-1707-1. Epub 2013 Jan 5.

  PMID: 23292667 BACKGROUND

• Runco DV, Zimmers TA, Bonetto A. The urgent need to improve childhood cancer cachexia. Trends Cancer. 2022 Dec;8(12):976-979. doi: 10.1016/j.trecan.2022.07.005. Epub 2022 Aug 3.

  PMID: 35931609 BACKGROUND

• Pilz F, Vill K, Rawer R, Bonfert M, Tacke M, Heussinger N, Muller-Felber W, Blaschek A. Mechanography in children: pediatric references in postural control. J Musculoskelet Neuronal Interact. 2022 Dec 1;22(4):431-454.

  PMID: 36458382 BACKGROUND

• Lurz E, Patel H, Lebovic G, Quammie C, Woolfson JP, Perez M, Ricciuto A, Wales PW, Kamath BM, Chavhan GB, Juni P, Ng VL. Paediatric reference values for total psoas muscle area. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):405-414. doi: 10.1002/jcsm.12514. Epub 2020 Jan 9.

  PMID: 31920002 BACKGROUND

• Gotte M, Gauss G, Dirksen U, Driever PH, Basu O, Baumann FT, Wiskemann J, Boos J, Kesting SV. Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. Pediatr Blood Cancer. 2022 Nov;69(11):e29953. doi: 10.1002/pbc.29953. Epub 2022 Sep 8.

  PMID: 36073842 BACKGROUND

• Gauss G, Beller R, Boos J, Daggelmann J, Stalf H, Wiskemann J, Gotte M. Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Front Pediatr. 2021 Aug 19;9:682496. doi: 10.3389/fped.2021.682496. eCollection 2021.

  PMID: 34490156 BACKGROUND

• Garcia MB, Ness KK, Schadler KL. Exercise and Physical Activity in Patients with Osteosarcoma and Survivors. Adv Exp Med Biol. 2020;1257:193-207. doi: 10.1007/978-3-030-43032-0_16.

  PMID: 32483741 BACKGROUND

• Furtado S, Errington L, Godfrey A, Rochester L, Gerrand C. Objective clinical measurement of physical functioning after treatment for lower extremity sarcoma - A systematic review. Eur J Surg Oncol. 2017 Jun;43(6):968-993. doi: 10.1016/j.ejso.2016.10.002. Epub 2016 Oct 14.

  PMID: 27836415 BACKGROUND

• Ehrhardt MJ, Leerink JM, Mulder RL, Mavinkurve-Groothuis A, Kok W, Nohria A, Nathan PC, Merkx R, de Baat E, Asogwa OA, Skinner R, Wallace H, Lieke Feijen EAM, de Ville de Goyet M, Prasad M, Bardi E, Pavasovic V, van der Pal H, Fresneau B, Demoor-Goldschmidt C, Hennewig U, Steinberger J, Plummer C, Chen MH, Teske AJ, Haddy N, van Dalen EC, Constine LS, Chow EJ, Levitt G, Hudson MM, Kremer LCM, Armenian SH. Systematic review and updated recommendations for cardiomyopathy surveillance for survivors of childhood, adolescent, and young adult cancer from the International Late Effects of Childhood Cancer Guideline Harmonization Group. Lancet Oncol. 2023 Mar;24(3):e108-e120. doi: 10.1016/S1470-2045(23)00012-8. Epub 2023 Feb 14.

  PMID: 37052966 BACKGROUND

• Bhagat A, Kleinerman ES. Anthracycline-Induced Cardiotoxicity: Causes, Mechanisms, and Prevention. Adv Exp Med Biol. 2020;1257:181-192. doi: 10.1007/978-3-030-43032-0_15.

  PMID: 32483740 BACKGROUND

• Basteck S, Guder WK, Dirksen U, Krombholz A, Streitburger A, Reinhardt D, Gotte M. Effects of an Exercise Intervention on Gait Function in Young Survivors of Osteosarcoma with Megaendoprosthesis of the Lower Extremity-Results from the Pilot Randomized Controlled Trial proGAIT. Curr Oncol. 2022 Oct 14;29(10):7754-7767. doi: 10.3390/curroncol29100613.

  PMID: 36290890 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms; Sarcoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Exercise Oncology Working Group

Model Details: Bicentric feasibility trial

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 20, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 28, 2025

Record last verified: 2024-11

Locations

DE (2)