Resistance vs. Aerobic Training on Breast Cancer Patients Undergoing Neoadjuvant Treatment

NCT05297773 | Recruiting

• 2 other identifiers: Neo-program 2021.02.23NEO-Program
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

Exercise; Quality of life; Neoadjuvant treatment; Tumor biology; Physical fitness; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Changes from baseline Ki67% at the end of the intervention

  Initial tumor biopsy and the post-neoadjuvant surgical specimen will be evaluated. Pathology evaluation will include the Ki67 assessment. The time frame depends on each participant's treatment plan.

  4-6 months

Secondary Outcomes (12)

• Changes in body mass index (BMI) from baseline to T1 and T2

  4-6 months

• Changes in hip circumferences from baseline to T1 and T2

  4-6 months

• Changes in waist circumferences from baseline to T1 and T2

  4-6 months

• Changes in bone mineral density from baseline to T1 and T2

  4-6 months

• Changes in lean body mass from baseline to T1 and T2

  4-6 months

Other Outcomes (14)

• Changes from baseline to T1 and T2 in Fatigue-FACIT scale

  4-6 months

• Changes in depression and anxiety from baseline to T1 and T2

  4-6 months

• Subjective Changes in sleep quality from baseline to T1 and T2

  4-6 months

Study Arms (3)

Aerobic Training

EXPERIMENTAL

Three sessions per week during 4-6-months according to each individual treatment plan. Participants allocated in this group will perform moderate-to-vigorous intensity cycling exercise.

Behavioral: Aerobic Training Group

Resistance training

EXPERIMENTAL

Three sessions per week during 4-6-months according to each individual treatment plan. Participants allocated in this group will perform weight-machine strength exercises of the upper and lower body.

Behavioral: Resistance Training Group

Control Group

ACTIVE COMPARATOR

One session per week of relaxation/stretching.

Other: Control group

Interventions

Aerobic Training Group BEHAVIORAL

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.

Also known as: AT, moderate continuous cycling

Aerobic Training

Resistance Training Group BEHAVIORAL

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.

Also known as: RT, machine-weight training

Resistance training

Control group OTHER

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

Also known as: Relaxation/stretching group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacao Champalimaud: lead
• Faculdade de Motricidade Humana - Universidade de Lisboa: collaborator

Study Sites (2)

Faculdade de Motricidade Humana - Universidade de Lisboa

Lisbon, Cruz-Quebrada, 1495-751, Portugal

ACTIVE NOT RECRUITING

Fundação Champalimaud

Lisbon, Lisbon District, 1400-038, Portugal

RECRUITING

Related Publications (1)

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Sleep Initiation and Maintenance Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Inês R. Correia, MSc

  Faculdade de Motricidade Humana - Universidade de Lisboa

  STUDY CHAIR

Central Study Contacts

Maria-João Cardoso, MD

CONTACT

+351 210400200; maria.joao.cardoso@fundacaochampalimaud.pt

Luís B Sardinha, Ph.D.

CONTACT

+351 214149116; lsardinha@fmh.ulisboa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Breast Surgeon - Medical Doctor

Model Details: Participants will be followed in a randomized controlled trial conducted during the full duration of neoadjuvant treatment (i.e. 4- to 6-months, depending on patient treatment plan) and two cohorts will be defined: A - breast cancer patients undergoing chemotherapy; B - breast cancer patients undergoing endocrine therapy. Within each cohort, the participants will be divided into three groups: 1) aerobic training; 2): resistance training; 3): control group. The intervention is designed to have equal energy expenditure throughout the exercise sessions in both exercise groups (10 kcal/kg/week). All training groups will complete 3 sessions/week. To ensure that both exercise groups are isoenergetic, a portable gas analyzer will be used and blood lactate will be collected. Mandatory thematic sessions about several topics such as physical activity guidelines, active lifestyle will be implemented.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 28, 2022
• Study Start: December 16, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)