Exercise for Cancer

Not currently recruiting at 10 trial locations

Overseen By Jessica Scott, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise (also known as physical activity, workout, or fitness training) might prevent cancer recurrence by lowering a blood marker called ctDNA. Researchers are testing various exercise levels to determine which is the most practical, safe, and effective in reducing ctDNA. Participants should have completed treatment for breast, prostate, or colorectal cancer and be at high risk of relapse. Those who have finished cancer treatment but do not exercise regularly might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on exercise and cancer prevention.

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 prior data suggests that this exercise protocol is safe for cancer patients?

Research has shown that exercise can safely improve cancer outcomes. For example, studies have found that lung cancer patients who exercised had a 24% lower risk of dying from cancer. Similarly, colon cancer survivors who followed a three-year exercise program had a 28% lower chance of their cancer returning. Another study showed that patients in a structured exercise program had a 37% lower risk of death. These findings suggest that exercise is not only safe but may also help cancer survivors live longer.

This trial focuses on different levels of exercise for cancer survivors. Exercise is generally well-tolerated, and the trial aims to determine the safest and most effective amount. Researchers will closely monitor participants to ensure their safety. Overall, exercise appears to be a promising and low-risk way to help prevent cancer recurrence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a treatment option for post-treatment colorectal and breast cancer patients because it offers a non-invasive approach to potentially reduce the risk of cancer relapse. Unlike traditional treatments like chemotherapy, radiation, or targeted therapy, exercise doesn't rely on drugs, which means fewer side effects and a focus on enhancing overall health and well-being. This trial aims to find the right dosage of exercise that is both feasible and tolerable for patients, which could pave the way for a new standard of care that incorporates physical activity as a core component of cancer recovery and relapse prevention.

What evidence suggests that exercise might be an effective treatment for preventing cancer recurrence?

Research shows that exercise can greatly benefit cancer survivors. Studies have found that regular exercise can lower the chance of cancer recurrence. For example, colorectal cancer patients who exercise regularly demonstrate better heart and lung fitness, increased strength, and reduced body fat. One study found that after five years, those who followed a structured exercise program had an 80% chance of remaining cancer-free, compared to 74% for those who only received health education materials. Exercise is also linked to lower risks of breast and colorectal cancer, suggesting it might help prevent cancer from returning. These findings indicate that exercise could be a powerful way to support cancer recovery and reduce the risk of recurrence. Participants in this trial will follow different exercise regimens to determine the optimal dose for further evaluation. ^{6 7 8 9 10}

Who Is on the Research Team?

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9454950/

Physical Activity and Cancer Care—A Review - PMC Studies have shown that exercise improves aerobic fitness and upper-body strength and reduces BMI and body fat in colorectal cancer patients. The results of a ...

2. asco.org asco.org/about-asco/press-center/news-releases/movement-medicine-structured-exercise-program-challenge

Structured Exercise Program May Lower Risk of Cancer ... At five years, the disease-free survival rate was 80% in the structured exercise program and 74% in the health education materials group.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6522766/

Effect of exercise on colorectal cancer prevention and treatment Physical activity may prevent approximately 15% of the colon cancers. Furthermore, several observational studies have demonstrated the efficacy and dose- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S209525462500047X

Exercise and cancer outcomes: What do we know and ... Encouraging data showing exercise inversely correlated with breast cancer mortality. • Emerging data for colorectal and prostate cancer. • Initial data showing ...

5. nature.com nature.com/articles/s41467-020-14389-8

Physical activity and risks of breast and colorectal cancer Our results support a potentially causal relationship between higher physical activity levels and lower risks of breast cancer and colorectal cancer.

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2502760

Structured Exercise after Adjuvant Chemotherapy for Colon ... Preclinical and observational studies suggest that exercise may improve cancer outcomes. However, definitive level 1 evidence is lacking.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12181474/

Exercise and survival benefit in cancer patients Lung cancer patients who engaged in physical activity had a 24% lower risk of cancer-specific death (HR: 0.76, 95% CI: 0.69–0.84), while colorectal cancer ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6992637/

Physical activity and risks of breast and colorectal cancer Our results support a potentially causal relationship between higher physical activity levels and lower risks of breast cancer and colorectal cancer. Based on ...

9. aicr.org aicr.org/resources/blog/new-study-shows-benefits-of-physical-activity-for-colon-cancer-survivors/

New Study Shows Benefits of Physical Activity for Colon ... Colon cancer survivors who took part in a three-year structured exercise program had a 28 percent lower risk of cancer recurrence or a second ...

10. oncology-central.com oncology-central.com/world-first-trial-highlights-survival-benefits-of-exercise-for-colon-cancer/

World-first trial highlights survival benefits of exercise for ... Patients had over a third (37%) lower risk of death if they participated in the structured exercise program. Every year, around 31,800 people ...