Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma

NCT06962072 | Recruiting

• 1 other identifier: NL85908.018.23
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess body image, health-related quality of life (QoL), and functioning (gait function, joint function, and walking ability) in patients after resection of localized soft tissue sarcoma (STS) of the extremities. A secondary objective is to assess the influence of different variables (e.g., radiotherapy, ethnicity, etc.) on body image, health-related QoL, and functioning. Patients who underwent a surgical resection at the Amsterdam UMC between 2010 and 2021 will be approached to participate in the study. Participants will complete four questionnaires and undergo a physical examination. Additionally, they will have a 3D gait analysis, a 6-minute walk test with gas analysis, and a muscle strength assessment. Furthermore, muscle volume change will be evaluated on pre- versus postoperative MRI scans.

Conditions

Soft Tissue Sarcoma

Keywords

Soft tissue sarcoma; Body image; Quality of life; Function; Functioning

Outcome Measures

Primary Outcomes (15)

• Gait biomechanics

  A 3D gait analysis will be conducted. Ground reaction forces will be captured using two force plates embedded in the center of the walkway. Three valid gait trials will be collected (meaning a clear strike on the force plate(s)). For each trial, data on joint angles and net joint moments (via inverse dynamics) and powers around the hip, knee, and ankle will be calculated. Data will be averaged over three trials to represent the outcome. Also, spatiotemporal gait parameters, such as step length (m) step width (m) and walking speed (m/s} will be calculated.

  Baseline

• Range of motion in degrees

  Rang of motion in degrees wil be assessed during the physical examination using a goniometer

  Baseline

• Limb circumference in cm

  Limb circumference in cm will be measured during the physical examination

  Baseline

• Muscle strength in newton measured with a handheld dynamometer

  A handheld dynamometer will be used to measure muscle strength during the physical examination. The participant will be asked to lie or to sit in a specific position and resistance will be applied depending on the muscle group to be tested. The dynamometer will be held perpendicular to the tested limb and the participant will be asked to actively perform a maximum contraction against the dynamometer. The participants will be instructed to push as hard as they can, and the examiner will apply equal force to that of the participant. On each muscle group, three trials will be performed, and the highest record among the three trials will be recorded. Newton (N) will be used to express muscle strength.

  Baseline

• Muscle strength tested with the MRC scale

  Based on the clinician's assessment of the normal strength of the muscle group under examination, the scale rates muscle strength on a scale of 0 to 5, with 0 representing no visible contraction and 5 representing a movement against complete resistance.

  Baseline

• Muscle strength in newton meters measured with a Biodex dynamometer.

  Quantitative force of muscles in arms or legs will be assessed using a Biodex dynamometer. The measures will be performed on both sides. On each muscle group, three trials will be performed, and the highest recorded value will be used for the analysis. Peak torque will be calculated and recorded in newton meters (Nm). Peak torque is defined as the highest torque output produced by muscle contraction during a repetition.

  Baseline

• Change in muscle volume between preoperative and postoperative MRI scans

  The change in muscle volume between preoperative and postoperative MRI scans will be determined.

  Baseline

• Walking energy cost in J/kg/m

  Walking energy cost in J/kg/m will be determined during a 6-minute walk test with simultaneous gas analysis. The oxygen uptake (VO2) and carbon dioxide production (VCO2) are measured breath-by-breath using a portable gas analysis system. First, the energy consumption will be measured for 8 minutes while the subjects are sitting on a chair. Then, the energy cost will be measured while subjects are walking during a 6-minute walk test at a comfortable, self-selected speed on an indoor oval route.

  Baseline

• Walking speed in m/s

  Walking speed wil be assessed during the 6-minute walk test. It will be measured and calculated as the average speed over the steady state period.

  Baseline

• Time Up and Go (TUG) test

  In the TUG test, the time (in seconds) required for a patient to get up from a chair, walk 3 meters to a marked point on the ground, turn, walk back to the chair, and sit down will be recorded.

  Baseline

• Timed Up and Down Stairs (TUDS) test

  In the TUDS test, the time (in seconds) required for a patient to go up a flight of stairs quickly and safely, turn around on the top step, and descend to the bottom step with both feet landing on the ground will be recorded.

  Baseline

• Body image as assessed by the Body Image Scale (BIS)

  Body image after STS resection will be evaluated with the Body Image Scale (BIS). This questionnaire consists of 10 questions about body image. For each question, the patient has to choose between 'not at all' (score 0), 'a little' (score 1), 'quite a bit' (score 2), and 'very much' (Score 3). In total, a score between 0 and 30 can be achieved with 0 indicating no distress or symptoms and 30 indicating the highest level of distress and symptoms

  Baseline

• Health-related quality of life (QoL) as assessed by the Patient Reported Outcome Measurement Information System-Computerized Adaptive Test (PROMIS-CAT)

  Health-related QoL and activity limitations will be assessed using the PROMIS-CAT health domains: physical functioning, social role participation, pain interference, fatigue, upper extremity, and emotional distress (anxiety and depression). PROMIS instruments are scored with T-scores, which are standardized to the general population. The average of the reference population is set at 50 points, with a standard deviation of 10.

  Baseline

• Quality of life as assessed by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire

  This questionnaire is divided into two sections: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system consists of five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are five levels for each dimension. Patients will be asked to check the box next to the most suitable statement in every one of the five dimensions. For the EQ-VAS, patients will assess their health on a vertical visual analogue scale from 0 to 100 (0 being the worst and 100 being the best imaginable health).

  Baseline

• Level of pain as assessed by the Numeric Rating Scale (NRS)

  The level of pain will be assessed using the Numeric Rating Scale (NRS) 0 to 10. The pain will be measured at four intervals, with 0 being no pain at all and 10 being the worst pain imaginable: currently (1), average last week (2), severity pain when worst (3) or least (4).

  Baseline

Secondary Outcomes (9)

• Patient demographics

  Baseline

• Body Mass Index (BMI) in kg/m2

  Baseline

• Tumor characteristics

  Baseline

• Tumor size in cm

  Baseline

• Tumor volume in cm³

  Baseline

Study Arms (1)

Survivors following the resection of extremity soft tissue sarcoma

Patients who were treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010 and 2021.

Procedure: Surgical resection with or without radiotherapy and/or chemotherapy

Interventions

Surgical resection with or without radiotherapy and/or chemotherapy PROCEDURE

The surgical resection of STS serves as the primary treatment, aiming to completely remove the tumor with a wide margin of surrounding healthy tissue to minimize the risk of recurrence. Radiotherapy and/or chemotherapy may be incorporated depending on the tumor's type, stage, and grade.

Survivors following the resection of extremity soft tissue sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for primary non-metastatic extremity STS through surgical resection, with or without (neo-) adjuvant radiotherapy, between 2010-2021.

You may qualify if:

• Treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010-2021.
• Being able to visit the Amsterdam UMC, location AMC once or twice.
• Pregnant patients must agree to be scheduled 5 months after their pregnancy ends.

You may not qualify if:

• Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.

Sponsors & Collaborators

• Amsterdam UMC: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Floortje G.M. Verspoor, MD/PhD

CONTACT

+310205669111; f.g.verspoor@amsterdamumc.nl

Milad Makdis Mouso, Bachelor of medicine

CONTACT

m.makdismouso@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical researcher

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: May 8, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)