Ongoing Clinical Trials
22-149 Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
We are doing this study to find out the effects of exercise therapy on various indicators (signs) of prostate cancer in people with low-risk prostate cancer who are on active surveillance. We will look at the safety of exercise therapy and see whether it causes few or mild side effects in participants. We will also explore how the body responds to exercise therapy (such as changes in weight, blood pressure, and heart rate).
Some participants in this study will have assigned exercise therapy, and some participants will participate in their usual exercise routines. We will compare how the assigned exercise therapy and the usual exercise routines affect indicators of prostate cancer in participants.
The exercise therapy in this study will be regular home-based walking sessions on a treadmill, and that therapy will be assigned by an exercise physiologist. Walking on a treadmill is considered to be aerobic exercise—physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for 20-70 minutes.
Researchers have found that exercise (including aerobic exercise) can be an effective way to decrease the risk of cancer worsening in people with low-risk prostate cancer. However, researchers have not yet explored the effects of exercise therapy on particular indicators of prostate cancer in people on active surveillance. This study will provide valuable information about these indicators. We will use this information to design a larger study that focuses on whether exercise works against the growth and spread of prostate cancer in people on active surveillance.
22-364 Adaptive versus Standard Dosing of Aerobic Training in Patients Receiving Chemotherapy for Primary Breast Cancer
The purpose of this study is to find out how different amounts of aerobic training (AT) might improve cardiorespiratory fitness (CRF; lung, heart, blood vessel, and muscle function) in people while they are treated for breast cancer. We will compare standard AT (a fixed amount of walking each week) with adaptive AT (adjusting the amount of walking depending on how participants respond to the exercise). We will see how both study approaches (standard AT and adaptive AT) affect participants’ CRF. We will also look at whether the study approaches are safe and cause few or mild side effects in participants.
AT is exercise that stimulates and strengthens the heart and lungs and improves the body’s use of oxygen. In this study, the AT will be walking on a treadmill. Researchers have found that AT is a safe and effective way to improve CRF. Researchers have also seen that CRF is important for the health of people receiving treatment for their breast cancer. However, researchers have not yet found the level(s) of exercise that will be the most helpful for people undergoing cancer treatment. This study will provide useful information about how different levels of AT can affect the body and possibly improve the health of people receiving chemotherapy for breast cancer.
22-164 Dose-response of Aerobic Training During Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
The purpose of this study is to find the level of aerobic exercise that is practical, is safe, and has positive effects on the body that may reduce the side effects of TNT. The study will also look at the way the body responds to exercise and whether there are differences in TNT treatment. This will include looking at the highest TNT treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of TNT.
TNT is the standard treatment for your disease, but it can also cause side effects. For example, it can lower the number of white blood cells in the body, increasing the risk of infection. It can also lower the number of red blood cells, causing anemia which can make you feel tired because there are fewer red blood cells to carry oxygen throughout your body. Researchers have found that exercise can help manage these side effects of TNT. However, researchers have not yet found the level(s) of exercise that will be the most helpful for people. This study will provide useful information about how different levels of aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body’s use of oxygen) can affect the body and help reduce the side effects of TNT. About 216 people will take part in this study at Memorial Sloan Kettering Cancer Center (MSK).
20-378 Researching the Effect of Exercise on Cancer
The purpose of this study is to find the highest level of aerobic exercise that is practical, is safe, and has positive effects on the body that may prevent or slow the return of cancer. All participants in this study will have been previously treated for colorectal or breast cancer. Once we find the best level of exercise, we will test it further in a new group of participants.
This study will also look at the way the body responds to exercise and whether participants’ cancer comes back.
Researchers have found that measuring certain factors in the blood may help with predicting the risk of cancer returning. Researchers have been exploring the way exercise can change these factors and serve as an anticancer therapy. However, researchers have not yet found the level(s) of exercise that will be the most helpful for patients. This study will provide useful information about how different levels of exercise can affect these factors and possibly prevent or slow the return of cancer.
20-130 Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
The purpose of this study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of moderate to strenuous intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for several minutes at a time.
The researchers will study the effects of different exercise programs on how well the study participants’ bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.
19-486 Body’s Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.
Studies have shown that women who are overweight tend to have higher aromatase levels in their breast tissue. High aromatase levels can increase estrogen levels and cause tumor growth. Researchers think that exercise combined with a plant-based diet may help slow the growth of cancer by decreasing aromatase levels, promoting other positive changes in the body, and causing weight loss.
19-113 Exercise Treatment with Standard Therapy for Metastatic Breast Cancer:
The purpose of this study is to determine the amount of aerobic exercise that is beneficial to patients receiving initial therapy for newly diagnosed metastatic breast cancer that contains hormone receptors and is negative for the HER2 protein. Researchers believe that exercise may help delay the development of resistance to hormone therapy while slowing the growth of breast tumors.
The researchers will assess increasing amounts of weekly exercise (walking on a treadmill) in different groups of study participants. All participants in this study will be required to exercise for a certain number of minutes per week. A treadmill, activity tracker, and other equipment will be shipped to their homes for use during the study, and these items will be returned to Memorial Sloan Kettering when study participation is complete. Participants will communicate with the study team through virtual visits using an electronic tablet provided to them.
19-126 Researching the Effect of Aerobic Exercise on Cancer:
This study will test any good and bad effects of aerobic exercise. The study will look at how tolerable and feasible aerobic exercise is, and how it might change the biomarkers (signs of disease) found in the blood and tissue. Some studies suggest that exercise may be helpful for preventing recurrence or development of certain cancers. In this study, we will test the effects of aerobic exercise in four different groups.
18-534 Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors
The purpose of this study is to find the safest level of aerobic training for people about to undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on these patients and the outcomes of their cancers. This part of the study (Phase 0) will evaluate the feasibility and quality of at-home exercise and assessment procedures and find out whether study participants are willing to practice continuous lifestyle monitoring using apps and electronic devices.
Past Clinical Trials
21-101 Exercise Therapy in Cancer Patients Hospitalized for COVID-19: A Digitized Clinical Trial
We are doing this study to evaluate the safety of a 30-week aerobic exercise therapy program in cancer patients recovering from COVID-19. We will look at whether aerobic exercise therapy causes few or mild side effects in participants. The study will also provide information about how aerobic exercise therapy affects participants’ overall physical health (for example, body weight, blood pressure, sleep, heart rate, and lung function) and quality of life.
15-093: Dose Response of Aerobic Training in Postmenopausal Women at High Risk for the Development of Breast Cancer
This study is looking at the effect of different amounts of progressive exercise training on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in breast tissue. Previous studies have shown that more exercise may lower the risk of developing breast cancer. However, the best intensity and amount of exercise to cause this protective effect is not known. Similarly, how exercise reduces the risk of breast cancer is also not known. This study is designed to find out the optimal amount of exercise to change certain risk factors associated with developing breast cancer. We expect that exercise may change some but not all of these factors. This study is designed to find out which factors exercise changes, how much exercise changes these factors, and whether more exercise is associated with greater changes in these factors.
15-178: Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer
The purpose of this study is to compare the effects of aerobic exercise during and after chemotherapy for women who have been recently diagnosed with early-stage breast cancer. Previous studies have shown that aerobic exercise is a safe and tolerable activity for people with breast cancer. However, the best time to start an aerobic exercise training program is not known. This study is looking at the effects of aerobic exercise during and after chemotherapy. The results will be compared with the effects of completing no aerobic exercise at all.
17-327: Exercise Exposure Data Collection in People Undergoing Genomic Profiling (Using MSK-IMPACT™)
People are eligible to participate in this study if they have completed MSK-IMPACT genetic panel testing on protocol IRB#12-245 Genomic Profiling in Cancer Patients or IRB #06-107 Storage and Research Use of Human Biospecimens in the last three years. There is no exercise database at MSK, and the Exercise Oncology Service would like to create one. This database would collect information about tumor genetic results and individuals’ exercise history. A patient’s primary oncologist must approve of the program’s outreach to each person. There will be about 5,000 people taking part in this study.
For more information, contact the Exercise Oncology Service at 646-888-8103.
18-058: IIT: Integrative Profiling of Primary Breast Cancer on the Basis of Divergent Exercise Exposure
Those eligible to participate in this study have breast cancer and are getting surgery for the removal of the tumor. Samples from both tumor and normal breast tissue will be analyzed and compared with the amount of self-reported exercise.
Previous studies have shown that higher levels of regular exercise are associated with, in general, a reduction in the primary risk of breast cancer as well as a lower risk of breast cancer coming back after treatment. However, how regular exercise may alter this risk is not known. This study is designed to find out how engaging in regular exercise (or not) alters the biology of breast tumors as well as the normal tissue surrounding the tumor. Findings from this initial study may guide the design of future studies that will examine how changes in exercise alter breast tumor biology. About 40 people will take part in this study at Memorial Sloan Kettering.
For more information, contact the Exercise Oncology Service at 646-888-8103.
15-147: Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women with Operable Breast Cancer
The purpose of this study was to compare three approaches to exercise training in women with early-stage breast cancer who had completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early-stage breast cancer has shown that some treatments may have an adverse impact on physical fitness, leading to fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side effects. However, all of the exercise programs have followed essentially the same approach. This study was designed to see if a different approach to exercise training was more effective than the conventional approach in use.
15-215: Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Postsurgical Lung Cancer Patients
The purpose of this study was to compare the effects of different types of exercise with stretching in people with lung cancer. Aerobic training has been shown to be beneficial in people with lung cancer. This study compared the effects — good or bad — of aerobic training alone, a combination of aerobic training and resistance training, resistance training alone, or progressive stretching on the fitness of people with lung cancer.
15-274: Feasibility and Safety of Functional Performance Testing in People Undergoing Hematopoietic Cell Transplantation
The purpose of this study was to see if exercise fitness testing was feasible and safe in people at least 21 years old who were scheduled to undergo a hematopoietic stem cell transplant. Assessments in this study looked at body capacity before transplantation to see if these measures could help predict how people did after the transplant.
Assessments
Interested in one of these clinical trials, or are you preparing for a baseline testing appointment? Brief descriptions of some of the tests that trials may require is below. If you have questions, call 646-888-8103.
Body Composition Scan
Body composition is assessed using a dual-energy X-ray absorptiometry (DEXA) scan. DEXA uses a whole-body scanner and two different low-dose X-rays to read bone mass and soft tissue mass. It takes about 10 to 20 minutes to do a body scan. This test takes place at the Evelyn H. Lauder Breast Center or the Rockefeller Outpatient Pavilion.This test requires fasting from food, alcohol, tobacco, and caffeine for two hours before the test. Avoid strenuous activity for at least 12 hours before the test.
Fasting Research Blood Draw
The purpose of this blood draw is to measure certain circulating factors in the blood that may change because of exercise training. About 2 ounces of blood will be drawn. A portion of this blood is tested right away for a complete blood count, fasting glucose, and lipid values. The remaining blood is stored by Kryosphere, a company in North Carolina, and tested at a later point. Food, alcohol, tobacco, and caffeine should be avoided for eight hours before a fasting blood draw. Snacks (such as granola bars) are on hand after all fasting assessments are completed, or bring a snack of your choice.
Arterial Stiffness
This test looks at the function and health of the blood vessels. While you are lying down, a penlike device is gently pressed to your neck, your wrist, the back of your ankle, and your upper leg. Food, tobacco, and caffeine should be avoided for three hours before the test, and alcohol for ten hours before. Avoid strenuous activity for at least 12 hours before the test.
Flow-Mediated Dilatation
This test uses ultrasound to assess the blood flow in the body. You lie quietly while a blood pressure cuff is inflated around your arm or leg. After five minutes, the blood pressure cuff is deflated. Food and alcohol should be avoided for eight hours before the test, and tobacco, caffeine, and strenuous activity for 12 hours before.
Pulmonary Function Test
This test measures how well the lungs take in and release air, and how well they move gases from the atmosphere into the body. After taking a deep breath, you exhale into a mouthpiece as hard and fast as you can. You do this several times for approximately 15 minutes. Avoid food for two hours before the test and strenuous activity for 12 hours before.
Exercise (Fitness) Test
The purpose of this test is to assess the efficiency of the entire cardiovascular system. This test is similar to a cardiac stress test. During this test, you begin by walking on a treadmill at a constant speed. The speed or incline is increased every one to two minutes. The test is stopped when you can no longer walk at the desired speed or you become too tired to walk — usually after 12 to 15 minutes.
To accurately measure your fitness level, the air that you breathe out during the exercise test is analyzed. You will wear a mouthpiece during the test. This transports the air you breathe out into the testing computer for analysis.
To ensure your safety during the test, the electrical activity of your heart is monitored using a 12-lead electrocardiogram (EKG). Ten EKG electrodes (sticky pads) are placed on specific areas of your body to see how your heart responds to exercise.
Avoid food for two hours, tobacco and caffeine for three hours, alcohol for six hours, and strenuous activity for 12 hours before your test.
Echocardiogram at Rest and After Exercise
You have this test right before you start the exercise fitness test and again right after finishing the exercise fitness test. Echocardiogram uses ultrasound to take images of the heart. These images can help identify changes in heart function. During this test, you lie on your left side while a sonographer places a wand over your chest. The wand has a small amount of gel on the end, which will not harm your skin. This gel helps produce clearer pictures. The wand sends high-frequency sound waves to your heart that are sent back to the ultrasound machine as moving images. You may be asked to change position during the test so different areas of the heart can be seen. You may also be asked to hold your breath at times.
Exercise Questionnaire
This questionnaire asks about your recent physical activity.
Comprehensive Study Guide
Additional assessments may be conducted using Bluetooth connected biohealth devices. Those devices and monitoring assessments are detailed here.