Aerobic Exercise Training for Breast Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Nebraska Medical Center, Omaha, NE
Breast Cancer+1 More
Aerobic Exercise Training - Behavioral
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether aerobic exercise training can improve cognitive function in post-menopausal breast cancer survivors.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Aerobic Exercise Training will improve 12 primary outcomes, 4 secondary outcomes, and 2 other outcomes in patients with Breast Cancer. Measurement will happen over the course of baseline (Month 0).

baseline (Month 0)
Reach
Month 6
Change in brain volume
Change in resting state functional connectivity
Change in white matter integrity
Month 12
Change in Cancer-related Fatigue
Change in Cardiorespiratory Fitness
Change in cognitive flexibility
Change in executive function processing
Change in inhibitory control
Change in relational memory
Change in self-reported cognitive function
Change in short-term memory
Change in spatial working memory accuracy
Change in spatial working memory reaction time
Change in verbal memory
follow up (month 12)
Maintenance
post-intervention (month 6)
Adoption
Implementation

Trial Safety

Trial Design

2 Treatment Groups

Health Education (Control)
Aerobic Exercise Training

This trial requires 180 total participants across 2 different treatment groups

This trial involves 2 different treatments. Aerobic Exercise Training is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Aerobic Exercise Training
Behavioral
Breast cancer survivors randomized to the intervention group will participate in a moderate-intensity aerobic exercise program for 24 weeks.
Health Education (Control)
Other
Individuals randomized to Health Education will receive individual education and counseling related to general cancer-related health and support across 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise Training
2020
Completed Phase 4
~5110

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (month 0), post-intervention (month 6), follow up (month 12)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (month 0), post-intervention (month 6), follow up (month 12) for reporting.

Who is running the study

Principal Investigator
D. E.
Prof. Diane Ehlers, Assistant Professor
University of Nebraska

Closest Location

University of Nebraska Medical Center - Omaha, NE

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult female with first-time, primary diagnosis of Stage I-IIIa breast cancer
Post-menopausal at diagnosis (no menses for 12 mo.)
Post-surgery and completed primary adjuvant treatments (i.e., radiation and/or chemotherapy) within 6-24 months of study enrollment (current hormonal therapy eligible)
Sedentary except for casual lifestyle recreation. Sedentary will be defined as reporting 20+ minutes of exercise PA on 2 or fewer days per week within previous 6 months
Physician's clearance to participate in an exercise program
Agree to be randomized to exercise or control
Telephone Interview of Cognitive status (TICS-M) performance above impaired range (>21)
Provide informed consent
Fully vaccinated for COVID-19

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes breast cancer?

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Results from a recent clinical trial revealed that gender and age are strongly associated with breast cancer. The findings suggest that more studies should look at genetic and physiological bases rather than behavioral factors for breast cancer.

Unverified Answer

Can breast cancer be cured?

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On the basis of the survival and recurrence rates for patients treated with chemotherapy alone, the potential for cancer cure in breast cancer cannot be ruled out. However, this is only achievable if patients are treated at an early stage of the disease. Survival and recurrence rates with neoadjuvant chemotherapy are comparable to those obtained from patients treated with traditional adjuvant chemotherapy. Although some patients treated with chemotherapy have more advanced tumors at diagnosis, the long-term outcome with neoadjuvant chemotherapy may still be comparable to that seen in patients treated with standard adjuvant chemotherapy.

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How many people get breast cancer a year in the United States?

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The American Cancer Society estimates there will be 1.65 million new cases diagnosed annually in 2016. Breast tumor screening was first approved in the U.S. in 2004.

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What are the signs of breast cancer?

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Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include a lump or mass in the breast or feeling a lump, or nipple or skin thickening. Signs of axillary lymph node metastases include a lump in the axilla, a change in texture or color when touched or warmth from palpation of the axilla or lower extremities.

Unverified Answer

What is breast cancer?

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Breast cancer is a breast, breast tissue or ductal carcinoma; an ovarian cancer of the breast is sometimes called a "cystic breast cancer", and a triple-negative breast cancer is sometimes called a "basal-like carcinoma".\n

Unverified Answer

How serious can breast cancer be?

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Stage 4 is deadly cancer with a median survival of 9.6 months in this population. Stage 4 patients are typically postmenopausal women age 75-82 who are not receiving estrogen and have HER2 positive disease, have distant spread to lymph nodes or in rare cases to bones or brain. Stage 4 patients have a dismal rate of long-term survival as well.

Unverified Answer

What is the average age someone gets breast cancer?

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The data suggest that the average time from date of onset of symptoms to time of diagnosis of breast cancer is approximately 5.6 months, with considerable variation among individual cases. It was not possible to establish either a lower or a higher limit. However, the study sample represents a population from a general health clinic, so the general population may be closer to the mean. The delay from symptoms to diagnosis was longer in women who had more comorbidities or who had a shorter interval of diagnosis after onset of symptoms. The average interval from diagnosis of the earliest case to the earliest case was 2.5 years. For early stage breast cancer, the average interval between symptoms and definitive diagnosis in this population was 2.6 months.

Unverified Answer

What is the primary cause of breast cancer?

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Breast health counseling was provided for women with a personal history of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) that did not meet the NEDIC criteria, which suggested that breast cancer screening and screening mammography may have been useful. Breast health interventions have been shown to be effective in reducing breast cancer morbidity and mortality. Results from a recent paper demonstrates that in high-risk black women breast health counseling has a low but significant impact on breast cancer screening and screening mammography use.

Unverified Answer

Who should consider clinical trials for breast cancer?

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Many women with metastatic breast cancer are not eligible for clinical trials. However, clinical trials provide the opportunity for both disease control research and personalised treatment options.

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What is the survival rate for breast cancer?

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The American Joint Committee on Cancer estimates the five-yr survival is approximately 75% for women diagnosed with stage I/II disease. Stage III/IV disease may be more aggressive, and women with these stage codes (stage III/IV) tend to live less than a year, with 10 to 20% dying from their disease.

Unverified Answer

What are the latest developments in aerobic exercise training for therapeutic use?

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Aerobic exercise has the potential to be an important adjunct to standard chemotherapy regimens of breast cancer survivors, however, further clinical trials are necessary to determine treatment dosing and most optimal regimen for the therapeutic use of aerobic exercise training for breast cancer survivors.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Breast Cancer by sharing your contact details with the study coordinator.