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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a tailored exercise program, specifically the EXCEL Exercise Oncology Program, can benefit individuals living with or who have survived cancer. The goal is to provide exercise classes, either online or in-person, to help participants stay active and manage side effects from cancer or its treatments. Individuals diagnosed with cancer who can perform mild exercise might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to enhance well-being through exercise while contributing to valuable research.

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 prior data suggests that this exercise program is safe for individuals living with and beyond cancer?

Research has shown that exercise is safe and beneficial for people with cancer. In one study, 81.4% of the 290 participants who joined the EXCEL program continued with it, indicating that most find the program manageable.

The EXCEL program offers group exercise sessions with support to help change habits, available online or in-person. Early results suggest the program can improve the health of people with cancer, and there have been no major reports of negative effects, which is encouraging.

Exercise programs like EXCEL are designed to help people with cancer become active safely. Trained professionals lead these programs, ensuring exercises are performed correctly and safely. This makes them a promising option for those seeking to enhance their fitness and well-being after a cancer diagnosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional cancer treatments that focus primarily on medical interventions like chemotherapy, radiation, or surgery, the EXCEL Exercise Oncology Program offers a novel approach by integrating regular physical activity into the care plan. This program is unique because it emphasizes the potential benefits of exercise in improving overall well-being and possibly enhancing recovery and resilience against cancer. Researchers are excited about this approach as it may help boost patients' quality of life, increase strength and stamina, and reduce treatment side effects, all through a non-invasive and empowering method.

What evidence suggests that the EXCEL Exercise Oncology Program is effective for individuals living with and beyond cancer?

Research shows that exercise programs like EXCEL, which participants in this trial will engage in, can greatly help people living with and beyond cancer. Studies have found that these programs make everyday tasks easier. Early results from the EXCEL study showed that participants were very satisfied and saw improvements in their physical health. Exercise is a proven way to enhance overall well-being and manage cancer-related fatigue. Maintaining a regular exercise routine can help preserve strength and energy during and after cancer treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Nicole Culos-Reed, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772696724000036

Interim results and program satisfaction of the EXCEL study A total of 804 individuals living with and beyond cancer agreed to participate in the EXCEL study from Fall 2020 until Winter 2023 (8 total 12-week intervention ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9915392/

First-Year Implementation of the EXercise for Cancer to ... Implementation outcomes included retention, adherence, assessment completion rates, and adverse-event reporting. A total of 290 individuals living with cancer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04478851

EXCEL: Exercise for Cancer to Enhance Living Well Exercise is an evidence-based self-management strategy that benefits all cancer survivors.

4. bmjopen.bmj.com bmjopen.bmj.com/content/12/12/e063953

Implementing an exercise oncology model to reach rural ... Effectiveness of EXCEL is assessed through the functional fitness outcomes ... Community-Based exercise program effectiveness and safety for cancer survivors.

5. mdpi.com mdpi.com/1718-7729/32/3/181

Exploring Healthcare Provider Experiences with the ... The EXCEL (Exercise for Cancer to Enhance Living well) effectiveness–implementation study aims to improve access to exercise oncology resources for those LWBC ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06960291

Sustainable Implementation of the EXCEL Exercise ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11941420/

Exploring Healthcare Provider Experiences with the EXCEL ... EXCEL is an exercise intervention designed to address health disparities in access to exercise oncology resources for rural/remote individuals ...

8. academic.oup.com academic.oup.com/jncimono/article/2025/71/351/8237998

Considerations for delivery of live-remote exercise for people ... Exercise is safe and beneficial for people diagnosed with cancer. The use of live-remote exercise approaches, where exercise trainers deliver exercise programs ...