Clinical trial · Interventional
Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
NCT03916796CI-TRIAL-00057752terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Too many barriers to enrolling well going forward
Summary
Brief summary (as posted)
This is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and surgical resection for extremity or superficial trunk soft tissue sarcoma (STS). At enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Counseling Services | Other | — | UNRESOLVED |
| Enhanced Recovery after surgery | Other | — | UNRESOLVED |
| Exercise | Other | — | UNRESOLVED |
| Psychological screening with counselling services as needed | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
- description
- * Patients must be treated using daily image-guided radiotherapy * Dietary counseling at baseline * Exercise intervention throughout cancer rehabilitation protocol * Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling
- interventionNames
- Other: Exercise
- Other: Enhanced Recovery after surgery
- Other: Psychological screening with counselling services as needed
- Other: Dietary Counseling Services
- type
- EXPERIMENTAL
- label
- Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
- description
- * Patients must be treated using daily image-guided radiotherapy * Dietary counseling at baseline * Exercise intervention throughout cancer rehabilitation protocol * Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed soft tissue sarcoma of the extremity, or superficial trunk (abdomen or chest) * Planning to receive radiotherapy and surgical resection * At least 16 years of age. * ECOG performance status ≤ 3 * Able to complete the cancer rehabilitation protocol safely, as determined by a treating physician. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon. * Patients with deep retroperitoneal or abdominal STS * Patients who have received prior radiotherapy and, based on the treating radiation oncologist's opinion, may not safely be treated with protocol neoadjuvant radiotherapy. * Currently receiving any investigational agents. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test prior to starting radiotherapy. * HIV-positive patients whose CD4+ T-cell count is \< 350 cells/mcL. * Receiving concurrent chemoradiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.