Clinical trial · Interventional
Exercise and Soft Tissue Sarcoma
The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
NCT04921917CI-TRIAL-00107645recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effect of a neoadjuvant (i.e. pre-treatment) exercise regimen on extremity function and postoperative wound healing. The study group will include patients with a primary diagnosis of soft tissue sarcoma undergoing treatment with neoadjuvant radiation therapy and surgical resection. Patients with upper or lower extremity sarcomas will be considered for enrollment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant exercise therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard of care: neoadjuvant radiation therapy (NRT).
- type
- EXPERIMENTAL
- label
- Neoadjuvant Exercise Regimen
- description
- Subjects will receive conventional NRT in conjunction with a prescribed exercise regimen during the usual 10-week duration of NRT treatment prior to tumor resection.
- interventionNames
- Other: neoadjuvant exercise therapy
Primary outcomes (1)
- measure
- Number of patients with a wound complication after surgery as measured by wound complication form
- timeFrame
- Up to 24 weeks post-op
- description
- The wound complication form is a team developed form that asks about different complications that can arise after surgery. These complications include delayed wound healing, surgical site or periprosthetic infection, re-operation, and other invasive procedures necessitated by wound complications.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males and females within the ages of 18-85 2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist 3. Sarcoma of the upper or lower extremity location 4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection 5. Expected primary wound closure performed at the time at surgery 6. Any disease stage 7. Any tumor grade 8. Any histologic subtype 9. First or recurrent presentations 10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity 11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied 12. Must be able to comply with follow up visits 13. Must be able to provide own consent Exclusion Criteria: 1. Patients under the age of 18, or over the age of 85 2. Treatment plan that does not include neo-adjuvant radiation and surgical excision 3. Sarcoma location other than the upper or lower extremity 4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied 5. High dose steroid therapy (defined as \>5mg prednisone, or equivalent, with the last 30 days) 6. Active treatment with chemotherapy within the last 30 days 7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers) 8. Plan for post-operative radiation therapy 9. Underlying severe cardiopulmonary disease 10. Prior surgery, other than a biopsy, at the site of disease 11. Tumors that are ulcerative or fungating through the dermis at the time of presentation 12. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity 13. Vascular disease resulting in clinically apparent compromise in blood flow to the treatment extremity (i.e. peripheral vascular disease with diminished pulses, venous insufficiency with clinical evidence of vascular congestion) 14. Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c\>8) 15. Active deep vein thrombosis in the treatment extremity 16. Inability to comply with follow up visits 17. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
References
Publications (0)
Data not yet available
No reference posted for this study.