Soft Tissue SarcomaQOLSarcomaNCT05051059
Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients
A study testing Functional outcome and Health related quality of life (HRQoL) assessment in people with Soft Tissue Sarcoma and Bone Sarcoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Sarcoma, Bone Sarcoma
- What is being tested?
- Functional outcome and Health related quality of life (HRQoL) assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who underwent limb salvage surgery for bone or soft tissue sarcoma of the lower extremity at UZ Leuven
- 18 to 95 years old
- Patients should be at least one year post surgery
- Informed consent has obtained
Who cannot join
- Patients who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system
- Skeletally immature individuals
- No informed consent has obtained
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. These surgeries often leave the patients with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision that patients (and their parents) with primary bone sarcomas about the knee joint have to make, involves choosing the type of surgical procedure that will provide them with the outcome that meets their functional as well as aesthetic expectations.
In literature, the quality of life for patients with osteosarcoma around the knee joint after three different surgical procedures, that is, amputation, endoprosthetic reconstruction and rotationplasty was evaluated. There was found that patients treated with rotationplasty showed significantly higher functional scores compared to the two other groups of patients. Also, researchers investigated the long-term quality of life after bone sarcoma surgery around the knee joint and found that, despite the functional disability, survivors were busy with work, study, relationships, and sometimes they have founded a family.
Most published reports in the literature on assessment of gait in the lower-extremity sarcoma survivors were focused on bone sarcoma patients after wide resection and endoprosthetic reconstruction. To the knowledge of the investigator, there has been no published studies on gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these patients hinder the development of effective rehabilitation protocols for recovering movement after resection of STS in the lower limb.
Read the detailed description
Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. There have been dramatic improvements in the survival rate of sarcoma patients in the past 40 years owing to increasing effectiveness of chemotherapy. This, along with developments in imaging techniques, have led to earlier diagnosis and more accurate preoperative staging. It is estimated that there are nearly 50,000 survivors of bone and soft tissue sarcomas in the United States. 70% of those are younger than the age of 50 years. Whilst traditional treatment for bone tumors used to be amputation, advances in surgical techniques have made limb-salvage procedures a valid alternative method of treatment in 80-85% of patients with primary bone sarcomas.
Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. These surgeries often leave the patients with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision that patients (and their parents) with primary bone sarcomas about the knee joint have to make, involves choosing the type of surgical procedure that will provide them with the outcome that meets their functional as well as aesthetic expectations. In literature, the quality of life for patients with osteosarcoma around the knee joint after three different surgical procedures, that is, amputation, endoprosthetic reconstruction and rotationplasty was evaluated. There was found that patients treated with rotationplasty showed significantly higher functional scores compared to the two other groups of patients. Also, researchers investigated the long-term quality of life after bone sarcoma surgery around the knee joint and found that, despite the functional disability, survivors were busy with work, study, relationships, and sometimes they have founded a family.
There are few reports available in the literature on the quality of life in sarcoma survivors. It was found that elderly patients, retired patients, and those who live alone need more intensive psychological care. Female patients were found to cope poorly with their disease compared to male gender. It was also found that the physical status greatly influences the overall outcome and quality of life in this group of patients. This stresses the importance of enrolment in tailored rehabilitation programs.
Most published reports in the literature on assessment of gait in the lower-extremity sarcoma survivors were focused on bone sarcoma patients after wide resection and endoprosthetic reconstruction. In literature, the gait pattern after endoprosthetic replacement around the knee joint was studied and found that, despite decreased walking velocity, stride length, and stance phase of the operated limb, these patients still have a symmetrical gait. Also in another report, an electromyographic assessment of gait after bone sarcoma surgery about the knee showed prolonged activation of rectus femoris and hamstring muscles in the affected limb compared to a control group. Other researchers found that limb-salvage patients often adopt a "stiff-legged" gait pattern. These findings are of utmost importance for the development of efficient rehabilitation programs for these patients.
To the knowledge of the investigator, there has been no published studies on gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these patients hinder the development of effective rehabilitation protocols for recovering movement after resection of STS in the lower limb. Researchers investigated the knee extension strength and postoperative functional outcome after quadriceps resection for soft tissue sarcoma of the thigh. They found that knee extension strength decreased when the number of resected quadriceps increased and this was associated with lower functional scores. They concluded that good functional results can be expected if at least two quadriceps muscles are preserved. However, no detailed assessment of gait in this group of patients has been published.
- Conditions
- Soft Tissue Sarcoma, Bone Sarcoma
- Being tested
- Functional outcome, Health related quality of life (HRQoL) assessment
- Keywords
- Lower extremities, Health related quality of life, Functional outcome, Limb salvage surgery
- Medical subject headings
- Sarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional outcomeOther
3D-motion analysis and strength assessment
Health related quality of life (HRQoL) assessmentOther
Quality of Life Questionnaire C-30 (QLQ-C30), Impact on Participation and Autonomy Questionnaire (IPAQ) and Musculoskeletal Tumor Society Score (MSTS)
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue sarcoma of the thigh | Other | Patients who underwent surgical resection of a deep intramuscular soft tissue sarcoma of the thigh Receives: Other: Functional outcome; Other: Health related quality of life (HRQoL) assessment |
| Control group | No intervention | A group of healthy age-matched individuals will be identified out of an available gait lab database to compare the gait pattern with tha of the patient group |
| Bone or soft tissue sarcoma of the lower extremity | Other | Patients who underwent surgical resection of a bone or soft tissue sarcoma of the lower extremity Receives: Other: Health related quality of life (HRQoL) assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal Tumor Society Score (MSTS)
To determine the physical and mental health for patients with extremity sarcoma
Measured: Within a period of 1 year
Quality of Life Questionnaire C-30 (QLQ-C30)
To measure cancer patients' physical, psychological and social functions
Measured: Within a period of 1 year
Participation and Autonomy Questionnaire Questionnaire (IPAQ)
To measure health-related physical activity
Measured: Within a period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Oct 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazem Wafa, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051059
- Sponsor's protocol ID
- S63146
- Acronym
- QOLSarcoma
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2021
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No