What is the mechanism of action of this treatment?

The most common treatments for Soft Tissue Sarcoma (STS) include neoadjuvant therapies like radiation and chemotherapy, followed by surgical resection. Radiation therapy works by damaging the DNA of cancer cells, preventing their replication, while chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Surgical resection aims to remove the tumor along with a margin of healthy tissue to ensure complete excision. Incorporating exercise into the neoadjuvant regimen can improve physical conditioning, enhance blood flow, and boost immune response, potentially aiding in better treatment tolerance and recovery outcomes for STS patients.

What side effects are associated with this type of intervention?

The most common treatments for Soft Tissue Sarcoma (STS) include surgery, radiation therapy (RT), and chemotherapy. Surgery can lead to complications such as infection, bleeding, and challenges in wound healing, especially in previously irradiated fields. Radiation therapy is associated with side effects like skin irritation, fatigue, and long-term risks of secondary cancers and fibrosis. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to immunosuppression. The Neoadjuvant Exercise Regimen trial aims to mitigate some of these side effects by improving physical conditioning, enhancing blood flow, and boosting immune response, potentially leading to better overall treatment outcomes and quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for soft tissue sarcoma, including chemotherapy agents like doxorubicin and ifosfamide, which are often used in neoadjuvant settings to shrink tumors before surgery. Additionally, trabectedin and eribulin have been approved for specific subtypes of soft tissue sarcoma. These treatments aim to reduce tumor size and improve surgical outcomes, indirectly supporting physical conditioning and immune response by reducing tumor burden. While these drugs do not directly enhance blood flow or physical conditioning, their use in combination with supportive therapies like exercise regimens can potentially improve overall treatment efficacy and patient outcomes.

What other types of research exist?

Promising novel alternatives to a neoadjuvant exercise regimen for soft tissue sarcoma patients include: 1) Immunotherapy, which can enhance the immune response against cancer cells. 2) Targeted therapies, such as tyrosine kinase inhibitors, which can improve treatment efficacy and potentially enhance physical conditioning by reducing tumor burden. 3) Advanced radiation techniques, like proton therapy, which can precisely target tumors while sparing healthy tissue, potentially leading to better overall physical health. 4) Multimodal interventions combining nutrition and exercise therapy, as seen in programs like NEXTAC, which aim to improve overall physical conditioning and immune function.

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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

Must not have

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 congestion)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks post-op

Awards & highlights

Summary

This trial is testing if doing specific exercises can help people with soft tissue cancer in their arms or legs recover better and heal faster 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.

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.

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 below

Select...

My blood flow in limbs hasn't been reduced by surgery.

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I haven't had radiation or surgery on the tumor area before this study.

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My sarcoma is located in my arm or leg.

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My soft tissue sarcoma diagnosis has been confirmed by a specialist.

Select...

My treatment plan includes radiation before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery on a limb that affected its blood flow.

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I have blood flow problems in my limbs due to vascular disease.

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I have had radiation or surgery on the tumor area before this study.

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I am younger than 18 or older than 85.

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I have a severe heart or lung condition.

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I have not taken high doses of steroids in the last 30 days.

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My sarcoma is not located in my arms or legs.

Select...

My diabetes is not under control (A1c>8).

Select...

I have had surgery, not just a biopsy, on the cancer site.

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I have not had chemotherapy in the last 30 days.

Select...

I currently have a deep vein clot in the limb being treated.

Select...

I am scheduled for radiation therapy after surgery.

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My treatment plan does not involve radiation before surgery.

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My tumor is breaking through the skin.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with a wound complication after surgery as measured by wound complication form

Secondary study objectives

Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire

Number of inflammatory serum markers

Percent necrosis of tumor

+3 more

Trial 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).

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Soft Tissue Sarcoma (STS) include neoadjuvant therapies like radiation and chemotherapy, followed by surgical resection. Radiation therapy works by damaging the DNA of cancer cells, preventing their replication, while chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Surgical resection aims to remove the tumor along with a margin of healthy tissue to ensure complete excision. Incorporating exercise into the neoadjuvant regimen can improve physical conditioning, enhance blood flow, and boost immune response, potentially aiding in better treatment tolerance and recovery outcomes for STS patients.

Effects of acute exercise training on tumor outcomes in men with localized prostate cancer: A randomized controlled trial.Exercise-Based Interventions to Counteract Skeletal Muscle Mass Loss in People with Cancer: Can We Overcome the Odds?Effects of Exercise on Cancer Treatment Efficacy: A Systematic Review of Preclinical and Clinical Studies.