Exercise Program for Cancer

(ACE Trial)

Recruiting at 1 trial location

Overseen By Christopher Sellar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Unsafe for physical activity

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: 26

2570 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the ACE Program, a structured exercise plan for adult cancer survivors. The program aims to improve their physical well-being and quality of life through consistent, personalized exercise. It may also help prevent new cancers from developing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise for cancer patients, so it's best to discuss your medications with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for cancer?

Research shows that strength training can improve strength by 20-50% in cancer survivors, which is important for better physical function and quality of life. Exercise also helps reduce cancer incidence and mortality rates, and may improve physical function during and after cancer treatment. ^{1 2 3 4 5}

Is exercise safe for cancer patients?

Exercise is generally safe for cancer patients, with adverse events (unwanted effects) being rare and usually mild, such as muscle soreness or circulatory problems. Studies show that supervised exercise programs for both adults and children with cancer have a low incidence of serious adverse events, making exercise a recommended activity during and after cancer treatment. ^{6 7 8 9 10}

How does the exercise treatment for cancer differ from other treatments?

The exercise treatment for cancer is unique because it focuses on improving physical fitness, quality of life, and mental health through structured physical activity, unlike traditional cancer treatments that primarily target the disease itself. This approach is based on models like cardiac rehabilitation and is not yet standardized in cancer care, offering a novel way to address treatment side effects and potentially reduce recurrence risk. ^{11 12 13 14 15}

Research Team

Nicole Culos-Reed, PhD

Principal Investigator

University of Calgary

Margaret L McNeely, PT, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults over 18 with a cancer diagnosis who can do low-intensity exercise. It's open to those pre-treatment, currently receiving treatment, or up to 3 years post-treatment. Participants must be able to consent and understand English.

Inclusion Criteria

I am over 18 years old.

I have been diagnosed with cancer.

I am currently undergoing cancer treatment, have had treatment in the last 3 years, or need supportive exercise due to cancer or its treatment.

Exclusion Criteria

I cannot safely do physical activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Fitness Testing and Triage

Participants undergo fitness testing and are triaged to appropriate exercise programming

1-2 weeks

1 visit (in-person)

Exercise Intervention

Participants engage in aerobic, resistance, balance, and flexibility exercises twice weekly for 8-to-12 weeks

8-12 weeks

24 visits (in-person or virtual)

Follow-up

Participants are monitored for effectiveness outcomes such as physical fitness, quality of life, and healthcare utilization

One year

Optional Extension

Participants may continue with the exercise program on a fee-for-service basis after the initial 12 weeks

Treatment Details

Interventions

• Exercise

Trial Overview The study tests the Alberta Cancer Exercise (ACE) Program across clinics in Alberta. It aims to see if this community-based exercise program improves physical well-being and quality of life for cancer survivors and helps prevent secondary cancers.

Participant Groups

Group I: Exercise Intervention Experimental Treatment 1 Intervention

Participant exercise sessions will be conducted in groups of 10-15 under the direct supervision of the community-based exercise specialist. Sessions will be twice a week for 12-weeks. Participants will have the option to continue with the exercise program after the 12-weeks on a fee-for-service basis.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Cross Cancer Institute

Collaborator

Trials

62

Recruited

19,200+

Tom Baker Cancer Centre

Collaborator

Trials

30

Recruited

8,900+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Findings from Research

Strength training (ST) significantly improves maximal strength in cancer survivors, with increases ranging from 20% to 50%, demonstrating its effectiveness in countering treatment-related declines in strength.

While ST also enhances physical function by 7% to 38%, improvements in body composition and psychosocial parameters were less consistent, indicating that strength gains are the most reliable benefit across various cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. Hanson, ED., Wagoner, CW., Anderson, T., et al.[2018]

Exercise interventions during and after cancer treatment, particularly resistance training, show promising physiological and psychological benefits, as highlighted in a review of 26 studies, mostly involving breast cancer patients.

Despite the positive outcomes, many studies lack robust designs, such as randomized controlled trials, and often have small sample sizes, indicating a need for more comprehensive research across various cancer types to better understand the dose-response effects of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of exercise intervention studies in cancer patients. Galvão, DA., Newton, RU.[2022]

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]

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]

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 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 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]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

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 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]

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

The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. [2018]

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

Review of exercise intervention studies in cancer patients. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects and potential mechanisms of exercise training on cancer progression: a translational perspective. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise interventions for cancer patients: systematic review of controlled trials. [2022]

5. 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]

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. 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]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

10. 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]

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

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]

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

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

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

Exercise Training in Cancer Control and Treatment. [2019]

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

Research and commentary: Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. [2006]

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

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