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Prehabilitation for Soft Tissue Sarcoma
N/A
Recruiting
Led By Krista A Goulding
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2, 6, and 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether patients who receive a tailored prehabilitation exercise regimen during radiotherapy have better surgical outcomes than those who do not.
Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of deep soft tissue sarcoma in the lower extremity, who can consent to participate. It's not for those with metastatic disease, tumors in superficial locations relative to fascia, or involvement of both upper and lower limbs.
What is being tested?
The study tests if a personalized exercise program (prehabilitation) during radiotherapy before surgery improves recovery and surgical outcomes for patients with soft tissue sarcomas compared to standard care without prehabilitation.
What are the potential side effects?
While this trial focuses on exercise and education rather than drugs, potential side effects may include typical risks associated with physical therapy such as muscle soreness or strain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2, 6, and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2, 6, and 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Daily step count
Efficacy potential
Feasibility as measured by recruitment, retention, adherence, and acceptability
+3 moreSecondary study objectives
Global health related quality of life
Symptom status
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (prehabilitation physical therapy)Experimental Treatment6 Interventions
Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.
Group II: Arm II (educational materials)Active Control5 Interventions
Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Physical Therapy
2020
Completed Phase 4
~1280
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,435 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,145 Total Patients Enrolled
Krista A GouldingPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer has spread to distant parts of my body or to my lymph nodes.Both my arms and legs are affected.My cancer is contained in one area.My gender does not limit my participation.My sarcoma is located near the surface of my body.My sarcoma is in the deep tissue of my leg and has been confirmed by tests.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (prehabilitation physical therapy)
- Group 2: Arm II (educational materials)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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