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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. 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 the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.

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 Moderate Exercise for Cancer-Related Fatigue in Breast Cancer?

Research shows that exercise, including moderate exercise, can help reduce cancer-related fatigue in breast cancer patients. Studies indicate that exercise interventions lead to improvements in fatigue, although the changes may be small. ^{1 2 3 4 5}

Is moderate exercise safe for people with cancer-related fatigue?

Research shows that moderate exercise, like walking, is generally safe for people with cancer-related fatigue, including those undergoing breast cancer treatment. Studies have not reported significant safety concerns, and many participants successfully adhered to exercise programs without major issues. ^{1 3 6 7 8}

How does exercise differ from other treatments for cancer-related fatigue in breast cancer patients?

Exercise, particularly combined aerobic and resistance exercise, is unique in its ability to significantly alleviate cancer-related fatigue both during and after cancer treatment, making it more effective than other treatments like yoga or regular physical activity. ^{1 2 3 8 9}

Research Team

Brett Lewis, M.D., Ph.D

Principal Investigator

Hackensack UMC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Does exercise intensity matter for fatigue during (neo-)adjuvant cancer treatment? The Phys-Can randomized clinical trial. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Physical activity, fatigue and quality of life in breast cancer patients. [2019]

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

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

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

A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Perceived physical fatigability improves after an exercise intervention among breast cancer survivors: a randomized clinical trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

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

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

Which Exercise Approaches Work for Relieving Cancer-Related Fatigue? A Network Meta-analysis. [2023]