Comparing resistance and aerobic exercise in breast cancer patients undergoing treatment
Effects of Resistance vs. Aerobic Training on Ki-67 and Other Health-Related Biomarkers: The NEO-Program, a Randomized Controlled Trial on Breast Cancer Patients Undergoing Neoadjuvant Treatment
This study is testing whether resistance training or aerobic exercise can help breast cancer patients undergoing treatment feel better and improve their health compared to a relaxation group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacao Champalimaud Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Lisbon, Cruz-Quebrada and 1 other locations) |
| Trial ID | NCT05297773 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of two different exercise protocols, resistance training and aerobic training, on breast cancer patients receiving neoadjuvant treatment. Participants will be randomly assigned to one of the exercise groups or a relaxation control group, with the primary outcome being changes in Ki-67%, a marker of tumor proliferation. Secondary outcomes will include assessments of body composition, physical fitness, quality of life, and various biological markers related to tumor characteristics. The study seeks to fill gaps in current knowledge regarding the impact of exercise during the neoadjuvant period, which has been under-researched compared to post-surgery interventions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically confirmed breast cancer (stage 0-III) who are scheduled for neoadjuvant treatment and have not engaged in structured exercise in the past six months.
Not a fit: Patients with a history of other cancers in the past five years, uncontrolled heart disease, diabetes, severe psychological disorders, or other medical conditions that prevent exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and treatment outcomes for breast cancer patients through tailored exercise interventions.
How similar studies have performed: While some pilot studies have suggested feasibility and potential benefits of exercise during neoadjuvant therapy, this approach remains relatively novel and underexplored in human subjects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically breast cancer (stage 0-III); scheduled for neoadjuvant treatment (cohort A - chemotherapy; cohort B - endocrine therapy) * Women aged ≥ 18 years; nonpregnant * Do not be involved in any structured exercise program in the past 6 months * Medical approval to participate in the study * Willingness to attend exercise sessions Exclusion Criteria: * Treated for any cancer in the past 5 years (except basal cancer) * Uncontrolled heart disease (heart failure, uncontrolled coronary heart disease, and uncontrolled hypertension, cardiac disease) * Diabetes mellitus * Lung condition (chronic obstructive or restrictive pulmonary disease) * Psychological disorders (dementia, Alzheimer, and Parkinson Disease) * Severe disability, or other medical condition that prevents from exercise training * Alcohol or drugs abuse
Where this trial is running
Lisbon, Cruz-Quebrada and 1 other locations
- Faculdade de Motricidade Humana - Universidade de Lisboa — Lisbon, Cruz-Quebrada, Portugal (Active_not_recruiting)
- Fundação Champalimaud — Lisbon, Lisbon District, Portugal (Recruiting)
Study contacts
- Study coordinator: Maria-João Cardoso, MD
- Email: maria.joao.cardoso@fundacaochampalimaud.pt
- Phone: +351 210400200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.