Exercise for Cancer-Related Fatigue in Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Chemotherapy, Metastases, Physical limitations, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether moderate exercise, such as using a pedal box for 15 minutes daily, can reduce the fatigue often experienced during breast cancer radiation treatment. Researchers aim to determine if regular, short exercise sessions can improve patients' well-being. Women with breast cancer who are new to radiation therapy and typically do not exercise much may be suitable for this study. Participants will either engage in the exercise or join a non-exercise group to compare results. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of exercise during cancer treatment.

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 prior data suggests that moderate exercise is safe for breast cancer patients experiencing fatigue?

Research shows that exercise is generally safe for people with cancer. Studies have found that moderate exercise, like that included in this trial, can help reduce fatigue in breast cancer patients. One study found a significant decrease in fatigue with exercise. Other research suggests that exercise can also alleviate other side effects of cancer treatment.

Regular exercise is already recommended for good health. For cancer patients, it is considered safe and beneficial. The National Cancer Institute advises aiming for 150 to 300 minutes of moderate exercise each week. This trial's exercise program fits well within those guidelines, with just 75 minutes a week.

Overall, moderate exercise is well-tolerated and linked to positive results. There are no major reports of harm from this type of activity, making it a safe option for managing cancer-related fatigue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about moderate exercise as a treatment for cancer-related fatigue in breast cancer patients because it offers a non-drug approach that can be easily integrated into daily routines. Unlike traditional treatments like medications or supplements that target fatigue, this approach involves just 15 minutes of exercise daily using a pedal box, which is simple and accessible. This method leverages physical activity to potentially boost energy levels and improve overall well-being, providing a natural and cost-effective alternative to manage fatigue.

What evidence suggests that moderate exercise might be an effective treatment for cancer-related fatigue?

Studies have shown that moderate exercise can help reduce tiredness in breast cancer patients undergoing treatment. In this trial, participants in the experimental arm will engage in moderate exercise, specifically 15 minutes a day using a pedal box before or after radiation at the hospital. Research has found that exercise improves fatigue levels, with a noticeable effect. Another study highlighted that low- to moderate-intensity exercise, such as aerobic or resistance training, positively impacts cancer-related tiredness. Regular exercise not only reduces fatigue but also improves heart health and overall quality of life. These findings suggest that incorporating moderate exercise could be a helpful way to manage tiredness during cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Brett Lewis, M.D., Ph.D

Principal Investigator

Hackensack UMC

Are You a Good Fit for This Trial?

This trial is for women aged 18-75 with non-metastatic breast cancer who are not currently pregnant or planning to become so, and have been sedentary. They must be about to start radiation therapy but can't be on chemotherapy or have had previous chest radiotherapy. A doctor's approval and a negative pregnancy test are needed.

Inclusion Criteria

I do less than 60 minutes of moderate exercise per week.

Negative serum pregnancy test and not planning to become pregnant in the next three months

I can walk on my own without help.

Exclusion Criteria

Physical limitations that contraindicate participation in low to moderate intensity exercise

My breast cancer has not been confirmed by tissue analysis.

I have had radiotherapy to my breast, chest, or pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation therapy for breast cancer, with concurrent moderate exercise intervention for the experimental group

4 weeks

Daily visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of fatigue, biomarkers, and quality of life

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Moderate Exercise

Trial Overview The study tests if moderate exercise for 15 minutes at a time can reduce fatigue caused by radiation therapy in breast cancer patients. The goal is to determine whether future recommendations should include exercise during treatment.

How Is the Trial Designed?

Group I: Moderate Exercise Experimental Treatment 1 Intervention

Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).

Group II: Control Group Active Control 1 Intervention

No exercise

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Lombardi Comprehensive Cancer Center

Collaborator

Trials

8

Recruited

1,200+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9715478/

Effects of exercise interventions on cancer-related fatigue ... Moderate certainty evidence indicated that exercise could improve fatigue in breast cancer patients (SMD = − 0.40 [95%CI − 0.58, − 0.22]; P = 0.0001).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003999323000527

Effectiveness of Therapeutic Exercise Models on Cancer ... The addition of low- to moderate-intensity aerobic and/or resistance exercise demonstrated a positive trend for improvement in CRF in patients with cancer ...

3. nature.com nature.com/articles/s41598-025-11660-0

Implementing exercise and self-management for women ... Engaging in regular exercise can reduce fatigue, improve cardiovascular fitness, and enhance overall quality of life11,12,13,14,15,16.

4. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-023-01363-0

Effects of exercise interventions on cancer-related fatigue and ... In this study, exercise interventions were evaluated for their effects on cancer-related fatigue (CRF) and quality of life (QoL) among cancer patients.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02846389

Trial of Exercise to Reduce Cancer Related Fatigue in ... The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in ...

6. cancer.gov cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet

Physical Activity and Cancer Fact Sheet - NCI How much physical activity is recommended? · 150 to 300 minutes of moderate-intensity aerobic activity, 75 to 100 minutes of vigorous aerobic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5981588/

Physical Activity, Exercise and Breast Cancer It appears that exercise can positively influence certain cancer- and treatment-related side effects, quality of life, recurrence, and survival.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0748798324006991

A cross-sectional study based on NHANES 2011–2020 High-intensity physical activity may decrease the risk of breast cancer, highlighting the importance of proactively implementing healthy lifestyle interventions ...

9. komen.org komen.org/breast-cancer/risk-factor/lack-of-exercise/

Breast Cancer Risk Factors: Exercise (Physical Activity) Overall, women who get regular exercise have a 10%-20% lower risk of breast cancer than women who aren't active.