RecruitingNot ApplicableNCT05297773

Resistance vs. Aerobic Training on Breast Cancer Patients Undergoing Neoadjuvant 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


Sponsor

Fundacao Champalimaud

Enrollment

132 participants

Start Date

Dec 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A recent consensus study suggested that understanding the impact of exercise on the tumor microenvironment and therapy effectiveness is paramount and should be considered as a research priority. Therefore, the research team intends to address some of the scientific challenges proposed, which represent clear gaps in the current knowledge. The investigators propose a randomized controlled trial conducted during all neoadjuvant treatment duration that aims to evaluate and compare the effects of two different exercise protocols (aerobic and resistance training) against a relaxation control group on Ki-67% changes as the main outcome in breast cancer patients. Secondary outcomes will be body composition; resting metabolic rate; physical fitness; quality of life, fatigue, depression/anxiety; accelerometry data (physical activity levels, sedentary time); sleep quality; tumor biology (size, hypoxia, and immune profile); glycemic, lipid, and inflammatory profile. This project will help not only researchers with the design of future exercise intervention protocols but will also help exercise physiologists in the decision-making process when defining training programs. Moreover, the investigators expect that this research program will encourage more cancer patients to exercise. The team expects that patients with breast cancer engaging in structured exercise will show a more marked decrease in Ki-67, tumor size, and hypoxia and increase the tumor-infiltrating lymphocytes (TILs) compared to controls. The investigators anticipate a more noticeable decrease in the preoperative endocrine prognostic index (PEPI) score and in the Residual Breast Cancer (RCB) in both training groups (respectively with hormonal and chemotherapy). Also, frequent declines in physical fitness are expected to be mitigated in exercisers. It is hypothesize that aerobic training will ameliorate cardiorespiratory fitness and fat mass, while the effects of resistance training will be more relevant for muscle strength, muscle mass, and bone health. Both exercise groups will show greater improvements in quality of life, fatigue, depression, anxiety, and sleep quality. Regarding glycemic, lipid, and inflammatory profiles, the investigators expect to see more favorable changes in both training groups, with a more evident decrease in fasting glucose and insulin, HbA1c%, total and LDL-cholesterol, and triglycerides, and the increase in HDL-cholesterol. The increase in C-reactive protein (CRP), tumor necrosis factor -α (TNF-α), interleukin-6 (IL-6), IL-8, IL-1β, IL-1ra, and insulin-like growth factor-1 (IGF-1) and the decrease in brain-derived neutrotophic factor (BDNF), IL-12p70, IL-10, oncostatin M will be smaller in exercise groups.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two types of exercise — resistance training (like weight lifting) versus aerobic training (like cycling or walking) — in breast cancer patients receiving pre-surgery treatment (neoadjuvant therapy). It aims to find which type of exercise better supports health during treatment. **You may be eligible if...** - You have been diagnosed with breast cancer (stage 0–III) and are about to start pre-surgery chemotherapy or hormone-blocking therapy - You are a woman aged 18 or older, and not pregnant - You have not been in a structured exercise program in the past 6 months - Your doctor has approved your participation **You may NOT be eligible if...** - You have been treated for another cancer in the last 5 years (except a minor skin cancer) - You have uncontrolled heart disease, heart failure, or uncontrolled high blood pressure - You have diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAerobic Training Group

The participants will perform continuous cycling at 30%-35% of their heart rate reserve for one month (phase 1: adaptive phase). Then, the intensity will increase every 4-5 weeks (± 5%) up to 80% of heart rate reserve (moderate intensity), depending on the participant's tolerance. An individualized equation establishing the relationship between heart rate, oxygen consumption, and power output will be determined during the cardiorespiratory fitness assessment and used to determine exercise intensity.

BEHAVIORALResistance Training Group

Initially, and during the first two weeks of the adaptive phase (1-month), the resistance training group will perform one set of 8-12 repetitions (40%-repetition maximum) of 8 exercises for upper and lower body (squat, leg extension, leg curl, deadlift, plank, dead bug, seated row, shoulder press). Then, in the last two weeks, the participants will perform 2 sets of each exercise (45%-repetition maximum). After the adaptive phase, three sets of each exercise will be performed. The initial load will be 50% -repetition maximum increasing up to a maximum of 70%-repetition maximum at the end of the study. Every 4-5 weeks the load will be reviewed and adjusted according to individual.

OTHERControl group

The control group will perform a weekly stretching/relaxation session for 45 minutes.


Locations(2)

Faculdade de Motricidade Humana - Universidade de Lisboa

Lisbon, Cruz-Quebrada, Portugal

Fundação Champalimaud

Lisbon, Lisbon District, Portugal

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NCT05297773


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