Exercise Program for Breast Cancer Fatigue

Overseen By Susan VanLoon, RN, CCRP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Virtua Health, Inc.

Disqualifiers: Psychotic disorders, Dementia, Chronic fatigue, others

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: 1

40 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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for managing fatigue in breast cancer patients?

Research shows that exercise can significantly reduce fatigue in breast cancer patients. Studies have found that a home-based moderate-intensity walking program can effectively lower fatigue levels during cancer treatment. ^{1 2 3 4 5}

Is exercise safe for breast cancer patients experiencing fatigue?

Exercise programs, including aerobic and resistance exercises, have been studied in breast cancer patients and are generally considered safe. These programs can help reduce fatigue and improve physical function without significant safety concerns. ^{2 5 6 7 8}

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

The exercise program for breast cancer fatigue is unique because it focuses on physical activity, which can improve both physical and psychological health by being enjoyable, skill-developing, and socially interactive. Unlike medications, this treatment involves moderate-intensity aerobic and resistance exercises, which can be tailored to individual needs and conditions, such as fatigue and nausea, to enhance overall well-being. ^{2 6 9 10 11}

What is the purpose of this trial?

Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.

Research Team

Priya P Gor, MD, MSCE

Principal Investigator

Penn Medicine

Eligibility Criteria

This trial is for English-speaking women over 18 with breast cancer, planning to undergo at least 4 chemotherapy cycles. They must be able to exercise (if cleared by a cardiologist), have an ECOG score <3, and own a device like a smartphone for reporting. It's not for those with exercise contraindications or certain medical/psychiatric conditions.

Inclusion Criteria

I can take care of myself but may not be able to do heavy physical work.

English-speaking with sufficient vision/hearing or family support

I am older than 18 years.

Exclusion Criteria

I have heart artery disease not approved by a heart doctor.

You have a reason that makes it unsafe for you to exercise.

Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive curative-intent chemotherapy while being assessed weekly for cancer-related fatigue and other symptoms

10-20 weeks

Weekly assessments via mobile phone, tablet, or computer

Follow-up

Participants are monitored for safety and effectiveness after chemotherapy, with assessments at 1, 3, and 6 months

6 months

Assessments at 1, 3, and 6 months post-chemotherapy

Treatment Details

Interventions

• Exercise

Trial Overview The study tests if home exercises can reduce fatigue in breast cancer patients during chemotherapy. Participants are randomly assigned to either control (no exercise) or intervention (exercise) groups, and they report their fatigue levels using specific tools online throughout the treatment period.

Participant Groups

Group I: Exercise Experimental Treatment 1 Intervention

Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

Group II: Control Active Control 1 Intervention

Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

Who Is Running the Clinical Trial?

Virtua Health, Inc.

Lead Sponsor

Trials

10

Recruited

690+

Carevive Systems, Inc.

Industry Sponsor

Trials

16

Recruited

1,100+

Findings from Research

Exercise interventions, particularly yoga and aerobic exercise, have been shown to significantly reduce cancer-related fatigue (CRF) in breast cancer patients, with a moderate effect size (SMD = -0.40) based on a review of 29 systematic reviews.

For optimal results, exercising at least three times a week for 30 to 60 minutes per session, especially under supervision, is recommended to effectively alleviate CRF in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions on cancer-related fatigue in breast cancer patients: an overview of systematic reviews. Zhou, HJ., Wang, T., Xu, YZ., et al.[2023]

Early breast cancer survivors (EBCS) reported mild fatigue levels that were not significantly different from inactive controls, suggesting that their fatigue may not be as severe as previously thought.

Fatigue in EBCS was linked to various psychosocial factors, including better physical and mental health, exercise expectations, self-efficacy, and lower levels of depression and anxiety, highlighting the importance of addressing these factors in fatigue management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline fatigue in early breast cancer survivors: understanding its prevalence in community-based exercise. Wagoner, CW., Lee, JT., Hanson, ED., et al.[2022]

A systematic review of 11 studies with 1530 cancer patients found that supervised physical activity significantly reduces cancer-related fatigue, with a strong effect size (SMD = -1.69).

Both combined aerobic and resistance training, as well as aerobic, resistance, and stretching exercises, were effective in reducing fatigue, suggesting these should be included in cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise reduces cancer-related fatigue: a systematic review. Meneses-Echávez, JF., González-Jiménez, E., Ramírez-Vélez, R.[2022]

A randomized controlled trial involving 119 sedentary women with breast cancer showed that a home-based moderate-intensity walking exercise program can significantly reduce fatigue levels during chemotherapy or radiation therapy, with a statistically significant effect (p=0.03) when accounting for actual exercise participation.

Despite 72% adherence to the exercise program, the overall analysis showed no group differences due to some participants in the usual care group also exercising; however, the results suggest that exercise can be an effective strategy to manage fatigue in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. Mock, V., Frangakis, C., Davidson, NE., et al.[2022]

A systematic review of 24 studies found that aerobic and resistance exercises are effective in reducing cancer-related fatigue (CRF) in breast cancer patients, with 21 reviews supporting this conclusion.

The overall quality of the systematic reviews was moderate to low, indicating that while exercise is beneficial, more rigorous research is needed to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for fatigue in breast cancer patients: An umbrella review of systematic reviews. Jiang, M., Ma, Y., Yun, B., et al.[2022]

An 18-week supervised exercise program starting within 6 weeks after breast cancer diagnosis significantly reduced physical fatigue during treatment compared to usual care, with a mean difference of -1.3 on fatigue scales.

The exercise intervention also improved submaximal cardiorespiratory fitness and muscle strength at 18 weeks, suggesting that early exercise can enhance physical well-being during cancer treatment, although these benefits diminished by 36 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. Travier, N., Velthuis, MJ., Steins Bisschop, CN., et al.[2022]

In a study involving 360 women with early breast cancer undergoing chemotherapy and radiotherapy, an Adapted Physical Activity Diet (APAD) program did not significantly reduce cancer-related fatigue compared to usual care, indicating limited efficacy in this context.

However, the APAD program was associated with a smaller proportion of patients experiencing confirmed depression at the end of follow-up, suggesting potential mental health benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial. Jacot, W., Arnaud, A., Jarlier, M., et al.[2021]

In a pilot study involving breast cancer survivors, a 12-week home-based aerobic exercise program significantly reduced fatigue levels, indicating its effectiveness in managing cancer-related fatigue.

The resistance exercise program improved functional capacity, as shown by a significant increase in the distance walked during a 6-minute test, suggesting it is a viable strategy for enhancing physical function in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise to alleviate fatigue and improve functional capacity among breast cancer survivors. Yuen, HK., Sword, D.[2022]

Therapeutic exercise programs for long-term breast cancer survivors showed initial benefits, such as reduced cancer-related fatigue and improved quality of life, but these positive effects were not sustained over time (≥ 5 years).

A significant portion (66.25%) of long-term breast cancer survivors remained inactive five years after completing the exercise program, and this inactivity was linked to higher levels of cancer-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does participation in therapeutic exercise programs after finishing oncology treatment still ensure an adequate health status for long-term breast cancer survivors? A ≥ 5 years follow-up study. Álvarez-Salvago, F., Jiménez-García, JD., Martínez-Amat, A., et al.[2023]

A study involving 64 women with chronic fatigue after breast cancer treatment found that both a multimodal mind-body program (MMMT) and a simple walking intervention significantly reduced fatigue symptoms over 10 weeks, with no significant difference in effectiveness between the two groups.

Both interventions also improved quality of life and functional well-being, leading researchers to recommend the more cost-effective home-based walking program since it provided similar benefits without the additional costs associated with MMMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a multimodal mind-body program enhance the treatment effects of physical activity in breast cancer survivors with chronic tumor-associated fatigue? A randomized controlled trial. Spahn, G., Choi, KE., Kennemann, C., et al.[2014]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions on cancer-related fatigue in breast cancer patients: an overview of systematic reviews. [2023]

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

Baseline fatigue in early breast cancer survivors: understanding its prevalence in community-based exercise. [2022]

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

Supervised exercise reduces cancer-related fatigue: a systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Exercise for fatigue in breast cancer patients: An umbrella review of systematic reviews. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. [2022]

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

Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial. [2021]

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

Home-based exercise to alleviate fatigue and improve functional capacity among breast cancer survivors. [2022]

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

Does participation in therapeutic exercise programs after finishing oncology treatment still ensure an adequate health status for long-term breast cancer survivors? A ≥ 5 years follow-up study. [2023]

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

Can a multimodal mind-body program enhance the treatment effects of physical activity in breast cancer survivors with chronic tumor-associated fatigue? A randomized controlled trial. [2014]

11. England pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]