Exercise for Breast Cancer Survivors

(BE-FITTER Trial)

Overseen By Stephen Foulkes, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Coronary artery disease, Heart failure, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise can improve heart and muscle health in breast cancer survivors who have undergone chemotherapy. Participants will engage in either a 12-week structured exercise program (Structured Exercise Training) or a 12-week stretching and yoga program (Group-based Yoga and Stretching) to assess which better enhances fitness. Women over 60 who have completed chemotherapy for early-stage breast cancer and are not currently in a structured exercise routine may be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance post-chemotherapy recovery strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on exercise programs for breast cancer survivors, so it's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that yoga benefits breast cancer survivors by reducing tiredness, depression, and anxiety, and improving sleep and overall quality of life. No serious side effects have been reported from yoga for these patients.

Research has shown that structured exercise training is safe and beneficial for breast cancer survivors. Exercise programs often improve physical fitness and reduce tiredness and pain, with no major safety concerns reported.

Both yoga and exercise training have been well-tolerated in past studies, with no significant risks noted. This suggests they are safe options for breast cancer survivors seeking to improve their physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for breast cancer survivors because they offer a unique approach to improving physical and mental well-being. Unlike traditional rehabilitation programs that may focus solely on one type of exercise, the group-based yoga and stretching treatment combines light-intensity yoga with balance and stretching exercises, providing a holistic approach that supports both physical and mental health. Meanwhile, the structured exercise training program is tailored to each individual's fitness level and medical history, offering a comprehensive regimen of aerobic and resistance training that is more personalized than standard options. These innovative strategies could enhance recovery and quality of life for breast cancer survivors in ways that current treatments may not fully address.

What evidence suggests that this trial's treatments could be effective for improving functional capacity in breast cancer survivors?

This trial will compare two different exercise interventions for breast cancer survivors. Participants may be assigned to the Group-based Yoga and Stretching arm. Previous research has shown that a six-month yoga program can lead to a 3% decrease in body fat and improved physical fitness. Yoga is also known to reduce tiredness, depression, and anxiety, while enhancing quality of life. Alternatively, participants may be assigned to the Structured Exercise Training arm. Studies have shown that regular exercise improves physical performance and reduces tiredness for breast cancer survivors. Exercise also boosts quality of life and physical ability, making it a helpful part of recovery. Both yoga and regular exercise have strong evidence supporting their benefits. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for older breast cancer survivors over 60 who've had chemotherapy that might affect the heart. They should be interested in improving their heart and muscle health, and increasing physical function. Participants must not have conditions that would limit safe engagement in exercise or yoga.

Inclusion Criteria

I am 60 years old or older.

I was diagnosed with early-stage breast cancer.

It's been over a year since I finished treatment with heart-risky cancer drugs.

Exclusion Criteria

I have a long-term heart rhythm problem.

I have had a stroke in the past.

I have a history of heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly enrolled in either a 12-week structured exercise training program or a 12-week stretching-yoga program to improve functional capacity, heart, and skeletal muscle function.

12 weeks

3 visits per week (in-person for exercise group), 1 visit per week (in-person for yoga group)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Group-based Yoga and Stretching
• Structured Exercise Training

Trial Overview The BE-FITTER Study compares a structured exercise training program with a group-based stretching-yoga program to see which is better at improving functional capacity, as well as heart and skeletal muscle function in older breast cancer survivors.

How Is the Trial Designed?

Group I: Experimental Arm: Structured Exercise Training Experimental Treatment 1 Intervention

Participants randomized to exercise training will be provided with a 12-week structured exercise training program. The program includes 3 weekly sessions of aerobic exercise (e.g treadmill, cycling, elliptical machine) and/or resistance training (i.e lifting weights). The aerobic sessions will include long-endurance (40-60 minutes at moderate intensity), tempo (30-40 minutes at a moderate-vigorous intensity) and high-intensity interval exercise (10-15 intervals of 30-60 seconds at 100% peak aerobic power output, interspersed with 60 seconds of active recovery). Resistance training will include 4-6 lower body exercises performed for 2-3 sets of 8-20 repetitions at a load equivalent to 60-85% of their one repetition maximum. The program will be supervised by an exercise trainer (Clinical Exercise Physiologist, Physiotherapist, Kinesiologist or Research Associate with exercise training experience) and will be individualized each individual's baseline fitness and medical history.

Group II: Active Comparator: Group-based Yoga and Stretching Active Control 1 Intervention

Participants allocated to the yoga and stretching group will provided with a once weekly yoga and stretching group class. The classes will consist of a combination of light-intensity yoga, balance and stretching exercises. The yoga and stretching class will be overseen by a yoga instructor, physiotherapist, physiotherapy trainee or research assistant with exercise training background

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

A six-month yoga-based exercise program for 20 breast cancer survivors led to significant improvements in physical fitness, including a 3% reduction in body fat and increased leg strength and flexibility.

Participants in the yoga group outperformed those in a comparison group on measures of forward reach, demonstrating that yoga can be a safe and effective exercise option for enhancing fitness in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a six-month yoga exercise intervention on fitness outcomes for breast cancer survivors. Hughes, DC., Darby, N., Gonzalez, K., et al.[2018]

Physical activity interventions are generally effective in improving the physical, mental, and social well-being of breast cancer survivors, based on a review of systematic reviews and meta-analyses.

Among various physical activities, yoga has been identified as the most effective complementary intervention to enhance the overall quality of life for breast cancer survivors, although the studies reviewed showed significant variability in their methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Practice of Physical Activity on Psychological, Mental, Physical, and Social Wellbeing for Breast-Cancer Survivors: An Umbrella Review. Zanghì, M., Petrigna, L., Maugeri, G., et al.[2022]

The study involved 63 breast cancer survivors across 66 group exercise counseling sessions, revealing that while a breast cancer diagnosis creates a common bond, factors like age and expectations can hinder group cohesion.

Key barriers to adherence included feelings of risk for cancer recurrence and people-pleasing behavior, highlighting the need for mental health referrals and effective behavioral modification techniques in group settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Rogers, LQ., Vicari, S., Courneya, KS.[2021]

A review of 71 studies indicates that yoga can improve quality of life (QOL) for women undergoing breast cancer treatment, enhancing aspects like physical well-being, emotional health, and social functioning.

Despite the positive findings, the review highlights the need for more rigorous research to pinpoint which specific elements of yoga are most beneficial for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga and quality-of-life improvement in patients with breast cancer: a literature review. Levine, AS., Balk, JL.[2012]

Yoga has been shown to have short-term benefits on psychological health in breast cancer patients, significantly reducing anxiety, depression, and perceived stress, based on a systematic review of 12 randomized controlled trials involving 742 participants.

While yoga also appeared to improve health-related quality of life, these effects were less clear and potentially influenced by bias, indicating that yoga is particularly beneficial during active cancer treatment rather than after.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for breast cancer patients and survivors: a systematic review and meta-analysis. Cramer, H., Lange, S., Klose, P., et al.[2022]

Exercise significantly benefits breast cancer survivors, with recommendations for moderate-intensity aerobic activity 3 to 5 days a week for 20 to 60 minutes, along with resistance training.

Psychological health improves with enjoyable exercise that includes social interaction and skill development, while modifications may be needed for conditions like fatigue or lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. Courneya, KS., Mackey, JR., McKenzie, DC.[2010]

Women with breast cancer undergoing chemotherapy who participated in a Tibetan yoga program (TYP) reported fewer daily sleep disturbances shortly after treatment compared to those in a stretching program (STP) and usual care (UC).

Long-term benefits in sleep quality were observed for TYP participants who practiced regularly (at least 2 times a week), showing improved sleep outcomes at 3 and 6 months after treatment compared to those who did not practice and those in the UC group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy. Chaoul, A., Milbury, K., Spelman, A., et al.[2019]

A systematic review of 16 randomized controlled trials involving 930 breast cancer patients found that yoga significantly improved health-related quality of life, depression, anxiety, and gastrointestinal symptoms compared to control groups.

The benefits of yoga were more pronounced when practiced for over 3 months, particularly in reducing anxiety, suggesting that longer durations of practice may enhance its effectiveness as a complementary therapy for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could yoga practice improve treatment-related side effects and quality of life for women with breast cancer? A systematic review and meta-analysis. Pan, Y., Yang, K., Wang, Y., et al.[2018]

After educational interventions, interest in yoga among older veterans who are cancer survivors significantly increased from 5.5% to 31.8%, indicating that knowledge can enhance engagement with yoga as a therapeutic option.

Participation in a yoga program led to improved beliefs about its benefits and physical function, particularly for those who initially had higher expectations about yoga, suggesting that targeted interventions can effectively address barriers to access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga. Auguste, EJ., Weiskittle, RE., Sohl, SJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8402960/

Feasibility of a yoga, aerobic and stretching-toning ... In this paper we present feasibility and acceptability data from a 12-week randomized controlled trial (RCT) conducted with adult cancer survivors.

2. withpower.com withpower.com/trial/phase-cardiotoxicity-6-2024-6b777

Exercise for Breast Cancer Survivors (BE-FITTER Trial) A six-month yoga-based exercise program for 20 breast cancer survivors led to significant improvements in physical fitness, including a 3% reduction in body fat ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26395825/

Effect of a six-month yoga exercise intervention on fitness ... This study reports on the improvements in physical fitness for 20 breast cancer survivors who participated in a six-month yoga-based exercise program (YE).

4. apm.amegroups.org apm.amegroups.org/article/view/59097/html

Effects of yoga on health-related quality, physical health and ... Conclusions: Yoga may benefit to reduce fatigue, depression and anxiety, improve sleep disturbance, and improve QoL in breast cancer patients receiving ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024119147

Effects of a tailor-made yoga program on upper limb ... This pilot trial revealed that the yoga program was feasible to be implemented for women with primary stage breast cancer. Although yoga was not ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4772898/

Effect of a six month yoga exercise intervention on fitness ... This study reports on the improvements in physical fitness for 20 breast cancer survivors who participated in a six-month yoga-based (YE) exercise program.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1462388925001139

Patient's expectations and experiences of yoga in group ... Although a recent study with breast cancer survivors revealed positive expectations regarding physical and mental wellbeing from yoga (Bilc et al., 2024) ...

8. link.springer.com link.springer.com/article/10.1007/s11764-021-01101-y

Feasibility of a yoga, aerobic and stretching-toning ... In this paper we present feasibility and acceptability data from a 12-week randomized controlled trial (RCT) conducted with adult cancer survivors.