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New treatment option for Soft Tissue Sarcoma
Official title Exercise and Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT04921917
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Males and females within the ages of 18-85
- Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
- Sarcoma of the upper or lower extremity location
- Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
- Expected primary wound closure performed at the time at surgery
You likely can't join if
- Patients under the age of 18, or over the age of 85
- Treatment plan that does not include neo-adjuvant radiation and surgical excision
- Sarcoma location other than the upper or lower extremity
- History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- High dose steroid therapy (defined as \>5mg prednisone, or equivalent, with the last 30 days)
- Active treatment with chemotherapy within the last 30 days
See the full eligibility criteria
- Males and females within the ages of 18-85
- Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
- Sarcoma of the upper or lower extremity location
- Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
- Expected primary wound closure performed at the time at surgery
- Any disease stage
- Any tumor grade
- Any histologic subtype
- First or recurrent presentations
- 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
- Must be able to comply with follow up visits
- Must be able to provide own consent
- Patients under the age of 18, or over the age of 85
- Treatment plan that does not include neo-adjuvant radiation and surgical excision
- Sarcoma location other than the upper or lower extremity
- History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- High dose steroid therapy (defined as \>5mg prednisone, or equivalent, with the last 30 days)
- Active treatment with chemotherapy within the last 30 days
- Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
- Plan for post-operative radiation therapy
- Underlying severe cardiopulmonary disease
- Prior surgery, other than a biopsy, at the site of disease
- Tumors that are ulcerative or fungating through the dermis at the time of presentation
- Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
- 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...
- Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c\>8)
- Active deep vein thrombosis in the treatment extremity
- Inability to comply with follow up visits
- Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.