Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
Status
Terminated
Conditions
Soft Tissue Sarcoma
Treatments
Other: Enhanced Recovery after surgery
Other: Dietary Counseling Services
Other: Psychological screening with counselling services as needed
Other: Exercise
Details and patient eligibility
About
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.
Enrollment
10 patients
Sex
All
Ages
14+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Supportive Care
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
10 participants in 2 patient groups
Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
Experimental group
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
Treatment:
Other: Exercise
Other: Psychological screening with counselling services as needed
Other: Dietary Counseling Services
Other: Enhanced Recovery after surgery
Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
Experimental group
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
Treatment:
Other: Exercise
Other: Psychological screening with counselling services as needed
Other: Dietary Counseling Services
Other: Enhanced Recovery after surgery
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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