CLINICAL TRIAL

neoadjuvant exercise therapy for Sarcoma

Recruiting · 18+ · All Sexes · Durham, NC

This study is evaluating whether a pre-treatment exercise regimen can improve extremity function and postoperative wound healing.

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About the trial for Sarcoma

Eligible Conditions
Soft Tissue Sarcoma (STS) · Sarcoma

Treatment Groups

This trial involves 2 different treatments. Neoadjuvant Exercise Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
neoadjuvant exercise therapy
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Sarcoma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Sarcoma of the upper or lower extremity location
Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 24 weeks post-op
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 24 weeks post-op.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether neoadjuvant exercise therapy will improve 1 primary outcome and 6 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of 6-week post-op.

The Musculoskeletal Tumor Society (MSTS) score
6-WEEK POST-OP
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Tissue Perfusion
6-WEEK POST-OP
Tissue Perfusion using the Near Infra-Red (NIRS) system
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
6-WEEK POST-OP
The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.
Number of inflammatory serum markers
LAST DAY OF NRT (UP TO 10 WEEKS OF NRT)
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Surgical Wound Assessment Form
UP TO 24 WEEKS POST-OP
Wound assessment and healing tracker tool created by the study team. The total score ranges from 13 to 65, with lower scores indicating better wound healing.
Number of patients with a wound complication after surgery as measured by wound complication form
UP TO 24 WEEKS POST-OP
The wound complication form is a team developed form that asks about different complications that can arise after surgery. These complications include delayed wound healing, surgical site or periprosthetic infection, re-operation, and other invasive procedures necessitated by wound complications.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes sarcoma?

Sarcoma occurs due to genetic mutations, environmental hazards, and infectious diseases. The exact causation for sarcomas is difficult to measure and is not always clear. It is important to understand that there are risks and benefits of developing sarcomas and knowing the risk of developing sarcomas in the future can assist in making better decisions in treatment and prophylaxis. Patients are the best experts when it comes to making treatment decisions because they know the risks and benefits for the type of cancer that they have. If a particular sarcoma is diagnosed, then the doctors and patients need to learn about the disease course, and the management of the disease both on the outside and at home.

Anonymous Patient Answer

How many people get sarcoma a year in the United States?

There are an estimated 1,092 new sarcomas per year in the United States. The sarcoma/cancer patient in the United States (22.7% of the cancer population) has a poorer prognosis than the sarcoma/cancer patient in Europe (15% of the cancer population). There also seems to be a gender difference between sarcomas and cancer overall (male:female=1.41 to male:female=1.15). The most common age group to be affected by sarcoma in the United States is 40-60 years (male:female=1.13).

Anonymous Patient Answer

What is sarcoma?

Sarcomas form in almost all tissue components and are a spectrum of tumor cells that exhibit a wide range of morphologies and biologic behaviors. Most cancer cells that generate sarcomas have the ability to undergo metastatic dissemination. As sarcomas are not typically benign, there is strong interest in developing therapies that target cells within cancer as they migrate throughout organs in an uncontrolled and invasive manner. The development of molecular therapies for sarcomas has increased immensely over recent years. Although only a small subset of cancer cells within sarcomas have the requisite mutations to undergo metastasis, it is possible to disrupt signals that lead to uncontrolled migration and spread of sarcoma cells throughout the body. Sarcomas are a spectrum of tumors.

Anonymous Patient Answer

What are common treatments for sarcoma?

Although aggressive therapy is often the standard treatment, patients are able to tolerate it. The response to chemotherapy can be poor in patients with poor performance status or in tumours with a high recurrence rate. Radiation has a significant place, and some forms of surgery may be carried out.

Anonymous Patient Answer

Can sarcoma be cured?

It is possible to cure sarcomas. More than 90% of sarcomas can be cured after appropriate surgery and chemotherapy. Most surgeons feel it's very important they work with the team to make the right diagnosis and treatment plan. A common reason for treatment failure is patients' reluctance to accept conventional chemotherapy, which can take months, if ever. We need more research in order to find a cure. If there is, there's a real possibility that most tumors can be cured.

Anonymous Patient Answer

What are the signs of sarcoma?

A slow-growing painless mass or firm lump may be present. Abdominal pain and swollen legs are both common, but only the latter appears to be a specific symptom for sarcomas.\n

Anonymous Patient Answer

What is neoadjuvant exercise therapy?

We observed no difference in outcome between patients undergoing Neoadjuvant EWT versus standard of care treatment alone. Neoadjuvant EWT in patients with locally advanced sarcomas is safe, feasible, well tolerated and can result in meaningful improvements in local progression-free and overall survival that translate into long-term improvements in quality of life and quality of life.

Anonymous Patient Answer

Does sarcoma run in families?

There is no evidence in the literature, and neither in our experience, of sarcomas in the patients' family members. An exception is the case of familial leukaemia; and although it can appear in patients with hereditary hematological disorders (e.g. haemoglobinopathies and hereditary leukaemias), it is more frequent in patients with sporadic cancers and/or in non-clonal leukaemias such as juvenile and adult acute myeloproliferative or chronic myeloproliferative (MPN/MPL) disorders.

Anonymous Patient Answer

Does neoadjuvant exercise therapy improve quality of life for those with sarcoma?

The present study found improved QOL and satisfaction scores for sarcoma patients receiving neoadjuvant ET that was equivalent to control groups who received only routine supportive care. A prospective trial of neoadjuvant ET may be considered for sarcoma patients.

Anonymous Patient Answer

What are the common side effects of neoadjuvant exercise therapy?

Neoadjuvant ET provides significant incremental benefit over concurrent ET for early distant metastatic disease control in NSCLC. Potential pharmacologic strategies include increased insulin-like growth factor-binding proteins, increased pro-oxidant capacity, decreased circulating microRNAs and hypoxia regulation, as well to increased expression of tumor suppressor p53 and p21/WAF-1. Further translational studies are required to determine the clinical impact that ET holds.

Anonymous Patient Answer

Who should consider clinical trials for sarcoma?

Clinically interesting sarcoma treatment options, including those not yet approved, are few in number. As a result, clinical trials are an important source of evidence, particularly for investigational agents that have not shown efficacy in earlier phase 3 clinical trials. Clinical trial evidence can help guide therapeutic decisions for sarcoma patients and their clinicians, providing critical insights as to treatment efficacy, and potentially altering therapy algorithms.

Anonymous Patient Answer

Have there been other clinical trials involving neoadjuvant exercise therapy?

The present study has a number of weaknesses that cannot be overlooked. Firstly, the number of patients in the trial is too small to draw conclusions; secondly the results of this trial has limited external validity, and three quarters of study participants dropped out before analysis. Thirdly, the study has the potential to be confounded by bias from investigators having either clinical knowledge or expectation of clinical benefit at baseline of the treatment being evaluated, which may influence the results of the study.

Anonymous Patient Answer
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