Exercise Program for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Neuromuscular, Cardiovascular, Psychological, others

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

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

150 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cancer Exercise Program for cancer patients?

Research shows that exercise can help reduce side effects like fatigue, depression, and pain in cancer patients, improving their quality of life during and after treatment. Exercise is beneficial for cancer patients at any stage, helping them manage treatment side effects and improve overall well-being. ^{1 2 3 4 5}

Is exercise safe for cancer patients?

Exercise programs for cancer patients, including those for children and adults, generally appear to be safe. Serious adverse events (unwanted effects) are rare, and most reported issues are mild, like muscle soreness or minor circulatory problems. Regular safety measures, such as breaks and medical consultations, help ensure safety during these programs. ^{6 7 8 9 10}

How is the Cancer Exercise Program treatment different from other treatments for cancer?

The Cancer Exercise Program is unique because it focuses on improving physical functioning and quality of life through structured exercise, rather than traditional medical treatments like chemotherapy or radiation. It is designed to be accessible and individualized, often provided in community settings or cancer centers, and aims to help cancer survivors regain strength and well-being during and after their main cancer treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

The investigators are examining the impact of an 8-week multi-modal exercise program (resistance and cardiovascular training) delivered 2 times per week on physical function adults (\>18 years old) with cancer.

Eligibility Criteria

Adults over 18 with a cancer diagnosis can join this trial. They must be willing to attend exercise sessions at the clinic and not have any health issues that make exercising unsafe. Participants also need to understand English.

Inclusion Criteria

I am over 18 and have been diagnosed with cancer.

Exclusion Criteria

I am not willing to visit the clinic for exercise sessions.

I do not have any health conditions that make exercising unsafe for me.

Unable to read/understand English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week multi-modal exercise program consisting of resistance and cardiovascular training, delivered 2 times per week

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cancer Exercise Program

Trial Overview The study is testing an 8-week exercise program, which includes resistance and cardiovascular training twice a week, to see how it affects physical function in adults with cancer.

Participant Groups

Group I: Exercise Experimental Treatment 1 Intervention

2 days/week of resistance and cardiovascular exercise for 8-weeks

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Findings from Research

Exercise is an effective therapeutic intervention for cancer patients, helping to reduce side effects from treatments and significantly improving their quality of life during and after treatment.

Engaging in exercise before, during, and after cancer treatments leads to numerous beneficial outcomes, making it a crucial part of care for both patients undergoing treatment and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Recommendations for Cancer-Related Fatigue, Cognitive Impairment, Sleep problems, Depression, Pain, Anxiety, and Physical Dysfunction: A Review. Mustian, KM., Sprod, LK., Janelsins, M., et al.[2021]

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 pilot trial involving 10 breast cancer patients undergoing neoadjuvant chemotherapy, adding a supervised exercise program resulted in a significant decrease in body mass index (BMI) compared to those receiving chemotherapy alone (28.0 vs. 35.8, P = 0.03).

While the exercise group showed a trend towards lower Ki-67 levels (7% vs. 29%, P = 0.14), indicating potential benefits in tumor proliferation rates, the difference was not statistically significant, suggesting further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. Rao, R., Cruz, V., Peng, Y., et al.[2021]

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 of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

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]

In a systematic review of 129 trials with 12,044 participants, exercise during systemic cancer treatment was associated with a higher risk of serious adverse events, thromboses, and fractures compared to control groups.

Despite these risks, exercise also correlated with a lower incidence of fever and a higher relative dose intensity of systemic treatment, indicating potential benefits, but the overall certainty of evidence regarding the harms and benefits of exercise in this context is very low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms of exercise training in patients with cancer undergoing systemic treatment: a systematic review and meta-analysis of published and unpublished controlled trials. Thomsen, SN., Lahart, IM., Thomsen, LM., et al.[2023]

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]

Community-based exercise programs for cancer survivors have been shown to significantly improve quality of life, reduce fatigue, and enhance overall well-being.

Engaging in regular physical activity may also lower the risk of recurrence for certain cancers, such as breast and colon cancer, highlighting the importance of exercise in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors. Musanti, R., Murley, B.[2018]

Exercise programs significantly improve various health indicators in adult cancer patients after completing their main treatment, particularly in areas like muscle strength, fatigue, depression, and quality of life, based on a review of 34 studies.

Patients with breast cancer showed notable benefits from aerobic exercise, with improvements in physical functions such as a 29-meter increase in 6-minute walk distance, highlighting the efficacy of exercise in enhancing recovery and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise programs for patients with cancer improve physical functioning and quality of life. McClellan, R.[2013]

The Breast Cancer Patients Engaging in Activity and Undergoing Treatment (BEAUTY) program is a 12-week evidence-based exercise initiative designed to improve the physical and psychological well-being of women undergoing chemotherapy or radiation for breast cancer, offered at no cost to participants.

The program aims to bridge the gap between research on the benefits of exercise for breast cancer recovery and practical community implementation, ensuring safety and adherence while enhancing quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. Leach, HJ., Danyluk, JM., Culos-Reed, SN.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise Recommendations for Cancer-Related Fatigue, Cognitive Impairment, Sleep problems, Depression, Pain, Anxiety, and Physical Dysfunction: A Review. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

Multimodal exercise ameliorates exercise responses and body composition in head and neck cancer patients receiving chemotherapy. [2019]

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

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a 12-Week Multimodal Exercise Intervention Among Older Patients with Advanced Cancer: Results from a Randomized Controlled Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

8. 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]

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

Harms of exercise training in patients with cancer undergoing systemic treatment: a systematic review and meta-analysis of published and unpublished controlled trials. [2023]

10. 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]

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

Community-Based Exercise Programs for Cancer Survivors. [2018]

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

Feasibility and efficacy of a supervised exercise intervention in de-conditioned cancer survivors during the early survivorship phase: the PEACH trial. [2022]

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

Exercise programs for patients with cancer improve physical functioning and quality of life. [2013]

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

Development, implementation, and effects of a cancer center's exercise-oncology program. [2020]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. [2022]