neoadjuvant exercise therapy for Sarcoma
This study is evaluating whether a pre-treatment exercise regimen can improve extremity function and postoperative wound healing.
See full descriptionAbout the trial for 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.
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.