Exercise for Cancer
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Other cancer, Metastatic malignancy, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for cancer patients?
Research shows that exercise can help cancer patients by reducing symptoms like fatigue and improving physical function. It may also lower the risk of certain cancers and help survivors recover better from treatment.
12345Is exercise safe for cancer patients?
Exercise is generally safe for most cancer patients and survivors, with guidelines recommending moderate to vigorous activity. Some studies report adverse events, but they are typically monitored and managed, making exercise a recommended part of cancer care.
678910How does the treatment of exercise differ from other treatments for cancer?
Exercise is unique as a cancer treatment because it not only helps improve physical and mental well-being but also has potential direct effects on cancer progression and treatment outcomes. Unlike traditional treatments like chemotherapy or radiation, exercise can enhance muscle strength, reduce fatigue, and improve overall quality of life without the side effects associated with drugs.
111121314Eligibility Criteria
This trial is for adults over 18 who've finished cancer treatment within the last 2 years for high-risk breast, prostate, or colorectal cancer. They should be non-exercisers (little to no regular exercise) and cleared for physical activity. People with other invasive cancers, serious illnesses, or those in another interventional study that could affect results are not eligible.Inclusion Criteria
I finished my cancer treatment between 1 month and 2 years ago.
My colorectal or breast cancer is considered high-risk after surgery.
I am 18 years old or older.
+3 more
Exclusion Criteria
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
I do not have any other type of invasive cancer.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose-Finding/Escalation
Participants undergo exercise therapy with escalating doses to determine the recommended phase 2 dose (RP2D) of exercise
24 weeks
Dose Expansion
An independent cohort receives the RP2D to evaluate feasibility, safety, and biological activity
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing how aerobic exercise affects ctDNA levels in blood—a marker that might predict cancer recurrence. Researchers will determine the most beneficial and practical amount of weekly exercise to potentially prevent cancer from returning.
2Treatment groups
Experimental Treatment
Group I: Dose-Finding/EscalationExperimental Treatment1 Intervention
Fifty (n=50) post-treatment patients with colorectal cancer or breast cancer, deemed high-risk of relapse. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial.
Group II: Dose ExpansionExperimental Treatment1 Intervention
An independent cohort of 30 post-treatment patients with colorectal (n=15) or breast (n=15) cancer deemed high-risk of relapse. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memoral Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, NJ
Memoral Sloan Kettering Westchester (Limited Protocol Activities)Harrison, NY
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Uniondale, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Exercise in cancer. [2021]Physical exercise has attracted increased interest in rehabilitation of oncological patients. The purpose of this paper is to review the literature and summarize the evidence of physical exercise in preventing cancer, its ability in attenuating the effect of cancer and its treatments and to provide guidelines for exercise prescription Review of recent literature by electronic search of MEDline (Pub Med), Cancer lit, Cochrane libraries, CINAHL were done using Keywords and the variables were identified and systematically evaluated. There is strong evidence for reduced risk of colorectal and breast cancer with possible association for prostate, endometrial and lung cancer with increasing physical activity. Exercise helps cancer survivors cope with and recover from treatment; exercise may improve the health of long term cancer survivors and extend survival. Physical exercise will benefit throughout the spectrum of cancer. However, an understanding of the amount, type and intensity of exercise needed has not been fully elucidated. There is sufficient evidence to promote exercise in cancer survivors following careful assessment and tailoring on exercise prescription.
Association between physical activity and mortality among breast cancer and colorectal cancer survivors: a systematic review and meta-analysis. [2023]Physical activity improves physical function during and after cancer treatment, but whether physical activity imparts survival benefit remains uncertain.
[Physical activity and exercise therapy in oncology]. [2023]Optimized and individualized treatment options in oncology significantly improve the prognosis of patients. Accordingly, the management of side effects and the avoidance of long-term consequences is becoming increasingly more important. Numerous studies have shown a positive impact of physical activity and targeted exercise therapy on certain patient-related outcomes. Ideally, patients are introduced to exercise therapy directly after the diagnosis is made in order to enable adequate supportive monitoring and to sustainably reduce therapy-associated side effects. Meanwhile, scientific findings have resulted in concrete recommendations for action to effectively improve the main patient-related outcomes, such as fatigue or depression. A moderate endurance training in combination with individualized strength training seems to be of particular importance. In principle, oncological training and exercise therapy can be recommended to every cancer patient regardless of the form of cancer and the timing of therapy but taking the contraindications into account. Therefore, the aim of communal as well as national efforts should be to implement a comprehensive offer of professional exercise therapy to facilitate access of cancer patients to these services as well as to ensure adequate care during and after treatment.
Physical exercise for cancer patients with advanced disease: a randomized controlled trial. [2021]Physical exercise can improve cancer patients' functioning and reduce their symptom levels. A randomized, controlled trial was launched to test the hypothesis that physical exercise reduces fatigue and improves physical performance in cancer patients with advanced and incurable disease.
[Doctor, is it reasonable for me to pursue a physical activity in my condition?] [2019]The prevalence of cancer is increasing, with an estimated number of new cases of 21.6 million worldwide by 2030. Progress in cancer therapies has turned it into a chronic disease. Physical exercise is essential both for the general population and for oncology patients. Practicing exercise reduces the risk of developing certain cancer types and, in oncologic patients, it can reduce symptoms secondary to the disease and to treatment as well as decrease the risk of relapsing. Encouraging adapted physical exercise to every oncologic patient is therefore essential (or crucial). It is recommended to practice regular physical activity equivalent to 150 minutes of moderate intensity or 75 minutes of high intensity activity per week.
[Effects of physical activity on cancer risk and disease progression after cancer diagnosis]. [2018]Numerous epidemiologic studies have demonstrated that regular physical activity convincingly reduces risk for colon cancer, probably for endometrium and postmenopausal breast cancer, and possibly for premenopausal breast, prostate, lung, and pancreas cancer. Relative risk reductions range from 10-30%. On the absolute scale about 9-19% of the most frequent cancers can be attributed to a lack of sufficient physical activity. Thus, exercise, as a modifiable health behavior, has a strong potential for primary cancer prevention. Current recommendations call for at least 30-60 min of moderate to vigorous activity daily. Physical activity is also increasingly gaining importance in cancer treatment and is now considered to be feasible, safe, and even recommended in almost all stages of disease. Randomized-controlled trials show that disease- and treatment-related symptoms, such as fatigue, sleep disorders, and depression which sometimes limit quality of life in cancer patients over years, can be reduced by physical activity. For disease-specific and total mortality, clinical studies are not yet available. However, preliminary observational studies with breast, colon, and prostate cancer patients show risk reductions.
Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]Purpose To evaluate the effects of exercise therapy on cardiorespiratory fitness (CRF) in randomized controlled trials (RCTs) among patients with adult-onset cancer. Secondary objectives were to evaluate treatment effect modifiers, safety, and fidelity. Methods A systematic search of PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library was conducted to identify RCTs that compared exercise therapy to a nonexercise control group. The primary end point was change in CRF as evaluated by peak oxygen consumption (VO2peak; in mL O2 × kg-1 × min-1) from baseline to postintervention. Subgroup analyses evaluated whether treatment effects differed as a function of exercise prescription (ie, modality, schedule, length, supervision), study characteristics (ie, intervention timing, primary cancer site), and publication year. Safety was defined as report of any adverse event (AE); fidelity was evaluated by rates of attendance, adherence, and loss to follow-up. Results Forty-eight unique RCTs that represented 3,632 patients (mean standard deviation age, 55 ± 7.5 years; 68% women); 1,990 (55%) and 1,642 (45%) allocated to exercise therapy and control/usual care groups, respectively, were evaluated. Exercise therapy was associated with a significant increase in CRF (+2.80 mL O2 × kg-1 × min-1) compared with no change (+0.02 mL O2 × kg-1 × min-1) in the control group (weighted mean differences, +2.13 mL O2 × kg-1 × min-1; 95% CI, 1.58 to 2.67; I2, 20.6; P < .001). No statistical significant differences were observed on the basis of any treatment effect modifiers. Thirty trials (63%) monitored AEs; a total of 44 AEs were reported. The mean standard deviation loss to follow-up, attendance, and adherence rates were 11% ± 13%, 84% ± 12%, and 88% ± 32%, respectively. Conclusion Exercise therapy is an effective adjunctive therapy to improve CRF in patients with cancer. Our findings support the recommendation of exercise therapy for patients with adult-onset cancer.
Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]Adequate, transparent, and consistent reporting of adverse events (AEs) in exercise oncology trials is critical to assess the safety of exercise interventions for people following a cancer diagnosis. However, there is little understanding of how AEs are reported in exercise oncology trials. Thus, we propose to conduct a scoping review to summarise and evaluate current practice of reporting of AEs in published exercise oncology trials with further exploration of factors associated with inadequate reporting of AEs. The study findings will serve to inform the need for future research on standardisation of the definition, collection, and reporting of AEs for exercise oncology research.
Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. [2021]Few studies have systematically evaluated the risk of adverse events (AEs) among persons exercising during oncological treatment. We aimed to describe incidence and types of AEs during exercise for persons undergoing oncological treatment, and associations to exercise intensity, exercise adherence, chemotherapy treatment, initial aerobic fitness. A second aim was to compare incidence of lymphedema, periphery inserted central catheter (PICC) complications, and other new medical conditions (any illness or injury occurred during the exercise trial) between high-intensity vs low-to-moderate exercise and usual care (UC).
Initiating Exercise Interventions to Promote Wellness in Cancer Patients and Survivors. [2022]Exercise is associated with significant reductions in the recurrence and mortality rates of several common cancers. Cancer survivors who exercise can potentially benefit from reduced levels of fatigue, and improved quality of life, physical function, and body composition (ie, healthier ratios of lean body mass to fat mass). The amount of activity required to achieve protective effects is moderate (eg, walking 30 minutes per day at 2.5 miles per hour). However, many healthcare providers report a lack of awareness of the appropriate exercise recommendations across the phases of cancer survivorship, considerations regarding the timing of exercise interventions, and the ability to refer patients to exercise programs specifically aimed at cancer survivors. The American College of Sports Medicine notes that exercise is generally safe for most cancer survivors, and inactivity should be avoided. Their guidelines for exercise call for 150 minutes of moderate or 75 minutes of vigorous aerobic activity per week, and 2 days per week of resistance training (eg, with exercise bands or light weights). Survivors with lymphedema, peripheral neuropathy, breast reconstruction, central lines, and ostomies should follow specific precautions. Providing health professionals with the training and tools needed to provide adequate recommendations to their patients is essential to improving patient outcomes. To facilitate adherence among communities with the greatest need and poor access to services, cultural and environmental adaptations are critical.
Exercise Training in Cancer Control and Treatment. [2019]Exercise training is playing an increasing role in cancer care, as accumulating evidence demonstrates that exercise may prevent cancer, control disease progression, interact with anti-cancer therapies, and improve physical functioning and psychosocial outcomes. In this overview article, we present the current state of the field of exercise oncology, which currently comprises of nearly 700 unique exercise intervention trials with more than 50,000 cancer patients. First, we summarize the range of these interventions with regard to diagnoses, clinical setting, timing, and type of intervention. Next, we provide a detailed discussion of the 292 trials, which have delivered structured exercise programs, outlining the impact of exercise training on cancer-specific, physiological, and psychosocial outcomes in the light of the challenges and physiological limitations cancer patients may experience. In summary, the safety and feasibility of exercise training is firmly established across the cancer continuum, and a wide range of beneficial effects on psychosocial and physiological outcomes are well documented. Many of these beneficial effects are linked to the general health-promoting properties of exercise. However, it is becoming increasing evident that exercise training can have direct effects on cancer and its treatment. This calls for future exercise oncology initiatives, which aim to target cancer-specific outcomes, and which are integrated into the concurrent cancer trajectory. Here, the field must bridge extensive knowledge of integrative exercise physiology with clinical oncology and cancer biology to provide a basis of individualized targeted approaches, which may place exercise training as an integrated component of standard cancer care. © 2019 American Physiological Society. Compr Physiol 9:165-205, 2019.
Can we HIIT cancer if we attack inflammation? [2019]Physical exercise offers numerous health-related benefits to individuals with cancer. Epidemiologic research has primarily been concerned with conventional exercise training that aligns with the recommendations of 150 min of moderate to vigorous physical activity per week. These recommendations are safe and effective at improving physical and psychosocial outcomes. Given the extensive evidence for generalized physical activity, researchers have begun to explore novel training regimens that may provide additional health benefits and/or improved adherence. Specifically, exercise at higher intensities may offer more or different benefits than conventional training approaches with potentially profound effects on the tumor microenvironment. This commentary focuses on the physiological effects of high-intensity interval training, also known as "HIIT," and its potential antineoplastic properties.
Effect of physical exercise on muscle mass and strength in cancer patients during treatment--a systematic review. [2018]Cancer treatment and its side effects may cause muscle wasting. Physical exercise has the potential to increase muscle mass and strength and to improve physical function in cancer patients undergoing treatment. A systematic review was conducted to study the effect of physical exercise (aerobic, resistance or a combination of both) on muscle mass and strength in cancer patients with different type and stage of cancer disease. Electronic searches were performed up to January 11th 2012, identifying 16 randomised controlled trials for final data synthesis. The studies demonstrated that aerobic and resistance exercise improves upper and lower body muscle strength more than usual care. Few studies have assessed the effect of exercise on muscle mass. Most studies were performed in patients with early stage breast or prostate cancer. Evidence on the effect of physical exercise on muscle strength and mass in cancer patients with advanced disease is lacking. More exercise studies in patients with advanced cancer and at risk of cancer cachexia are warranted.
A case study: prescriptive exercise intervention after bilateral mastectomies. [2004]Exercise for cancer patients is gaining support. In the current case study, a female breast cancer patient was diagnosed with breast cancer at the age of 29 years; she underwent a left modified radical mastectomy. She developed cancer again in the opposite breast at the age of 57 years and had a right modified radical mastectomy. After the second mastectomy (the right breast), the patient received chemotherapy and radiation. Following her cancer treatments, she participated in an exercise intervention for 6 months at the University of Northern Colorado's Rocky Mountain Cancer Rehabilitation Institute. A 6-month reassessment showed that she increased her muscular strength and cardiovascular function in addition to attenuating her cancer-related fatigue and depression. It is recommended that health professionals work together to ensure that a collaborative effort is undertaken to increase functional work capacity that will significantly improve patients' quality of life.