Exercise Programs for Cancer

(EXCEL Trial)

Recruiting at 4 trial locations

Overseen By Julianna Dreger, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: No cancer diagnosis, Under 18, others

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

Compensation: Varies

Number of Visits: 16

Duration: 8-12 weeks

740 Participants Needed

Trial Summary

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 seems focused on exercise programs, so it's likely you can continue your medications, but you should confirm with the trial organizers.

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

Exercise programs like EXCEL are shown to be safe and effective for cancer patients, improving physical fitness, well-being, and quality of life. They help reduce side effects of cancer treatments and enhance recovery, making them a valuable supportive care resource. ^{1 2 3 4 5}

Is exercise safe for cancer patients?

Exercise programs for cancer patients, like the EXCEL Exercise Oncology Program, are generally considered safe. Studies show that adverse events (unwanted side effects) are rare, and most are minor, such as muscle soreness or mild circulatory issues. No life-threatening events have been reported, making exercise a safe supportive care option for cancer patients. ^{1 5 6 7 8}

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

The EXCEL Exercise Oncology Program is unique because it focuses on making exercise accessible to cancer patients in rural and remote areas, improving their physical fitness, well-being, and quality of life, which is often not addressed by traditional cancer treatments. ^{1 2 5 9 10}

What is the purpose of this trial?

EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed. This study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.

Research Team

Nicole Culos-Reed, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for individuals in Canada living with and beyond cancer, including breast, prostate, uterine, and colon cancers. Participants should be interested in joining an 8 to 12-week exercise program that can be accessed online or possibly in person.

Inclusion Criteria

Be able to provide informed written consent in English or French

I have been diagnosed with cancer.

I can do light activities without much difficulty.

Exclusion Criteria

Is unable to participate in mild exercise, at minimum

Unable to read/write in English

For online programs, does not have internet or computer access

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in group exercise classes, twice a week for 8-12 weeks, delivered in-person or over a virtual platform

8-12 weeks

16-24 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in physical activity levels, cancer-related symptoms, and other health metrics

up to 1 year

Treatment Details

Interventions

• EXCEL Exercise Oncology Program

Trial Overview The EXCEL Exercise Oncology Program is being tested to see if it helps cancer patients incorporate exercise into their daily lives. The study compares a streamlined intake process with the original EXCEL Study and offers supervised classes twice weekly.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

All participants will be involved in group exercise classes, twice a week for 8-12 weeks.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

University of Prince Edward Island

Collaborator

Trials

17

Recruited

97,300+

Findings from Research

The EXCEL study aims to improve access to exercise oncology programs for approximately 1500 individuals living with cancer in rural and remote areas over a 5-year period, highlighting the importance of exercise as a safe and effective supportive care resource.

Participants will engage in a 12-week online multimodal exercise intervention, with outcomes assessed to evaluate the program's reach and effectiveness, ensuring that all cancer patients can benefit from improved physical fitness and quality of life regardless of their location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). Culos-Reed, N., Wagoner, CW., Dreger, J., et al.[2023]

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]

The STRENGTH trial involving 90 premenopausal breast cancer patients on chemotherapy demonstrated that home-based diet and exercise interventions can help prevent weight gain and preserve lean body mass during treatment.

The combination of a calcium-rich diet, exercise, and a high fruit and vegetable, low-fat diet led to a significant reduction in body fat percentage compared to the control group, highlighting the potential for dietary and exercise strategies to improve body composition in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Demark-Wahnefried, W., Case, LD., Blackwell, K., et al.[2021]

Exercise has been shown to positively impact various cancer-related toxicities, including fatigue, urinary incontinence, and lymphedema, based on recent reviews and randomized controlled trials.

Despite the evidence supporting exercise as beneficial for cancer patients, there is a lack of implementation of evidence-based exercise programs in clinical practice, highlighting the need for personalized treatment approaches like 'Oncologic clinical exercise' (OTT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence and recommendations for oncologic clinical exercise - a personalized treatment concept for cancer patients]. Baumann, FT., Hallek, M., Meyer, J., et al.[2015]

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]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

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]

References

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

Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). [2023]

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

Cost evaluation of an exercise oncology intervention: The exercise in all chemotherapy trial. [2023]

3. 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]

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

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Evidence and recommendations for oncologic clinical exercise - a personalized treatment concept for cancer patients]. [2015]

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

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

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

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

9. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, physical capacity, and health benefits of a multidimensional exercise program for cancer patients undergoing chemotherapy. [2018]

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

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