Exercise for Cancer

Recruiting in Basking Ridge (>99 mi)

+10 other locations

Overseen By Lee Jones, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Other cancer, Metastatic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 11 12 13 14}

Research Team

Lee Jones, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility 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.

Willingness to comply with all study-related procedures

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.

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

Treatment Details

Interventions

• Exercise

Trial Overview 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.

Participant Groups

Group I: Dose-Finding/Escalation Experimental Treatment 1 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 Expansion Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Regular physical exercise is associated with a reduced risk of developing colorectal and breast cancer, and may also lower the risk for prostate, endometrial, and lung cancers, based on a review of recent literature.

Exercise is beneficial for cancer survivors, aiding in recovery from treatment and potentially extending survival, although specific guidelines on the optimal amount, type, and intensity of exercise are still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cancer. Rajarajeswaran, P., Vishnupriya, R.[2021]

Engaging in physical activity before and after a cancer diagnosis significantly reduces the risk of total and cancer-specific mortality among breast and colorectal cancer survivors, with a notable decrease in risk observed for those who increased their activity levels post-diagnosis.

For every 10 metabolic equivalent task-hours per week of post-diagnosis physical activity, breast cancer survivors experienced a 24% reduction in total mortality risk, while colorectal cancer survivors saw a 28% reduction, highlighting the importance of maintaining an active lifestyle during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between physical activity and mortality among breast cancer and colorectal cancer survivors: a systematic review and meta-analysis. Schmid, D., Leitzmann, MF.[2023]

Physical activity and targeted exercise therapy can significantly improve outcomes for cancer patients, helping to manage side effects like fatigue and depression, especially when introduced right after diagnosis.

Moderate endurance training combined with individualized strength training is particularly effective and can be recommended for all cancer patients, regardless of cancer type, while ensuring contraindications are considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. Zoth, N., Böhlke, L., Theurich, S., et al.[2023]

In a study of 231 cancer patients with advanced and incurable disease, an 8-week supervised exercise program did not significantly reduce physical fatigue but led to notable improvements in physical performance, as measured by the Shuttle Walk Test and hand grip strength.

Despite the lack of impact on fatigue levels, the results suggest that physical exercise can help maintain physical capacity in cancer patients, making it a potentially beneficial intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise for cancer patients with advanced disease: a randomized controlled trial. Oldervoll, LM., Loge, JH., Lydersen, S., et al.[2021]

Regular physical exercise is crucial for both the general population and cancer patients, as it can reduce the risk of developing certain types of cancer and alleviate symptoms related to the disease and its treatments.

Oncology patients are recommended to engage in at least 150 minutes of moderate-intensity or 75 minutes of high-intensity exercise per week to help decrease the risk of cancer relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Doctor, is it reasonable for me to pursue a physical activity in my condition?] Bruno, B., Koessler, T., Bodmer, A.[2019]

Regular physical activity can significantly reduce the risk of several types of cancer, including colon, endometrial, and postmenopausal breast cancer, with relative risk reductions ranging from 10-30%.

Exercise is not only beneficial for cancer prevention but is also safe and effective in managing symptoms related to cancer and its treatment, improving quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of physical activity on cancer risk and disease progression after cancer diagnosis]. Steindorf, K., Schmidt, M., Ulrich, C.[2018]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[2022]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

In a study involving 577 participants undergoing cancer treatment, exercise was found to be safe, with 20% of adverse events (AEs) reported by coaches and 28% by participants, mostly being minor musculoskeletal issues.

High-intensity exercise was associated with a higher likelihood of AEs compared to low-to-moderate exercise, but both forms of exercise are recommended for patients if there are no medical contraindications, as serious complications like lymphedema and PICC issues were low and not significantly different across exercise intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. Henriksson, A., Johansson, B., Radu, C., et al.[2021]

Regular exercise significantly reduces the recurrence and mortality rates of several common cancers, and can improve quality of life and physical function in cancer survivors, with moderate activity like walking 30 minutes a day being effective.

The American College of Sports Medicine recommends 150 minutes of moderate or 75 minutes of vigorous aerobic activity per week for cancer survivors, emphasizing that exercise is generally safe and should be encouraged, while also noting the need for specific precautions for those with certain medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initiating Exercise Interventions to Promote Wellness in Cancer Patients and Survivors. Schwartz, AL., de Heer, HD., Bea, JW.[2022]

Exercise training has been shown to be safe and feasible for over 50,000 cancer patients across nearly 700 unique intervention trials, demonstrating significant benefits for both physical and psychosocial outcomes.

There is growing evidence that exercise not only promotes general health but also has direct positive effects on cancer progression and treatment, suggesting that it should be integrated into standard cancer care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training in Cancer Control and Treatment. Christensen, JF., Simonsen, C., Hojman, P.[2019]

Regular physical exercise, particularly at moderate to vigorous levels (150 minutes per week), is safe and effective for improving health outcomes in cancer patients.

High-intensity interval training (HIIT) may provide additional health benefits and could positively influence the tumor microenvironment, suggesting it might be a valuable alternative to conventional exercise regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we HIIT cancer if we attack inflammation? Papadopoulos, E., Santa Mina, D.[2019]

A systematic review of 16 randomized controlled trials found that both aerobic and resistance exercises significantly improve muscle strength in cancer patients compared to usual care.

Most studies focused on early-stage breast or prostate cancer, highlighting a need for more research on the effects of exercise in patients with advanced cancer and those at risk of muscle wasting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical exercise on muscle mass and strength in cancer patients during treatment--a systematic review. Stene, GB., Helbostad, JL., Balstad, TR., et al.[2018]

A case study of a breast cancer patient who underwent two mastectomies and subsequent treatments showed that a 6-month exercise intervention significantly improved her muscular strength and cardiovascular function.

The exercise program also helped reduce cancer-related fatigue and depression, highlighting the importance of collaborative health efforts to enhance the quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case study: prescriptive exercise intervention after bilateral mastectomies. Carter, SD., Drum, SN., Hayward, R., et al.[2004]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Exercise in cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Association between physical activity and mortality among breast cancer and colorectal cancer survivors: a systematic review and meta-analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Physical exercise for cancer patients with advanced disease: a randomized controlled trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Doctor, is it reasonable for me to pursue a physical activity in my condition?] [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

[Effects of physical activity on cancer risk and disease progression after cancer diagnosis]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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]

10. United States pubmed.ncbi.nlm.nih.gov

Initiating Exercise Interventions to Promote Wellness in Cancer Patients and Survivors. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Exercise Training in Cancer Control and Treatment. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Can we HIIT cancer if we attack inflammation? [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of physical exercise on muscle mass and strength in cancer patients during treatment--a systematic review. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

A case study: prescriptive exercise intervention after bilateral mastectomies. [2004]