Your session is about to expire
← Back to Search
Pre-Surgical Exercise for Soft Tissue Sarcoma
N/A
Recruiting
Led By William Eward, DVM, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks post-op
Awards & highlights
Study Summary
This trial will look at whether exercising before treatment for soft tissue sarcoma improves extremity function and heals wounds after surgery.
Who is the study for?
Adults aged 18-85 with a confirmed diagnosis of soft tissue sarcoma in an arm or leg, who will undergo radiation and surgery as part of their treatment. Candidates must be able to attend follow-up visits and give consent. Excluded are those with severe heart/lung disease, poor blood flow in the affected limb, prior surgeries (except biopsy), uncontrolled diabetes, active deep vein thrombosis, pregnancy, or recent chemotherapy.Check my eligibility
What is being tested?
The trial is testing how pre-treatment exercise affects limb function and wound healing after surgery in patients with soft tissue sarcoma. Participants will engage in an exercise regimen before receiving standard care consisting of radiation therapy followed by surgical removal of the tumor.See study design
What are the potential side effects?
While specific side effects are not listed for neoadjuvant exercise therapy, potential risks may include muscle soreness, fatigue, joint pain or injury related to physical activity especially when performed during cancer treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood flow in limbs hasn't been reduced by surgery.
Select...
I haven't had radiation or surgery on the tumor area before this study.
Select...
My sarcoma is located in my arm or leg.
Select...
My soft tissue sarcoma diagnosis has been confirmed by a specialist.
Select...
My treatment plan includes radiation before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with a wound complication after surgery as measured by wound complication form
Secondary outcome measures
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Number of inflammatory serum markers
Percent necrosis of tumor
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Neoadjuvant Exercise RegimenExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Standard of care: neoadjuvant radiation therapy (NRT).
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillOTHER
1,508 Previous Clinical Trials
4,190,592 Total Patients Enrolled
Duke UniversityLead Sponsor
2,360 Previous Clinical Trials
3,420,306 Total Patients Enrolled
William Eward, DVM, MDPrincipal InvestigatorDuke Orthopedic Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood flow in limbs hasn't been reduced by surgery.I have had surgery on a limb that affected its blood flow.My condition is at any stage.I am between 18 and 85 years old.I have blood flow problems in my limbs due to vascular disease.I have had radiation or surgery on the tumor area before this study.My cancer can be of any tissue type.I am younger than 18 or older than 85.I haven't had radiation or surgery on the tumor area before this study.I have a severe heart or lung condition.My sarcoma is located in my arm or leg.I have not taken high doses of steroids in the last 30 days.My sarcoma is not located in my arms or legs.My diabetes is not under control (A1c>8).My soft tissue sarcoma diagnosis has been confirmed by a specialist.I have had surgery, not just a biopsy, on the cancer site.My treatment plan includes radiation before surgery.I have not had chemotherapy in the last 30 days.My surgery wound is expected to be closed primarily.I currently have a deep vein clot in the limb being treated.My cancer can be of any severity.I am scheduled for radiation therapy after surgery.My treatment plan does not involve radiation before surgery.My tumor is breaking through the skin.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Neoadjuvant Exercise Regimen
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators at this moment recruiting participants for the experiment?
"Affirmative. Clinicaltrials.gov attests that this study, which was originally published on April 30th 2021, is currently seeking participants. 24 people are necessary to be enrolled at 1 medical location."
Answered by AI
Could I qualify to join this clinical experiment?
"To fulfill the requirements for this clinical trial, individuals should have been diagnosed with sarcoma and be within 18 to 85 years of age. Currently, approximately 24 people are needed as participants."
Answered by AI
What is the upper cap on patient enrollment for this clinical experiment?
"Correct. According to information on clinicaltrials.gov, this medical trial is actively seeking individuals to join. It was first posted in April 30th 2021 and has since been updated as recently as November 11th 2022. 24 participants are planned for recruitment from a single location."
Answered by AI
Are geriatric patients able to participate in the trial?
"The patient pool for this clinical trial is made up of individuals aged 18 or higher and 85 or lower."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger