Metabolic Flexibility in Patients With Early Triple-negative Breast Cancer

NCT07484776 | Active Not Recruiting DMC

• 1 other identifier: 2025-712
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer is considered a major global public health problem. It was estimated that in 2022 approximately 19.9 million new cancer cases were diagnosed worldwide, and this number is expected to increase over the next two decades to 28.0 million (1). Specifically, breast cancer (BC) represents the highest incidence worldwide, with approximately 2.3 million new cases diagnosed in 2022 (1). A higher incidence of BC is observed in developed countries, which may be due to high rates of obesity, alcohol and tobacco consumption, early onset of puberty, the use of contraceptives and hormonal therapies, low levels of physical activity, and giving birth at later ages (2,3). In addition to the factors mentioned above, hereditary factors and age also represent risk factors for cancer development (2,3). Finally, the presence of family members with breast and/or ovarian cancer carrying mutations in the BRCA1 or BRCA2 genes, among others, which increase the likelihood of tumor proliferation, as well as age over 40 years, also increase the probability of developing BC (2,3). Specifically, there is a molecular subtype that does not respond to hormonal receptors or HER2 and may be more aggressive and have fewer specific treatment options, known as triple-negative breast cancer (TNBC). Metabolic flexibility (MF) is described as the ability of the body to adapt to energy demands in different contexts. During chemotherapy and after surgery, significant changes may occur, such as increased body fat, loss of muscle mass, cancer-related fatigue, metabolic alterations, and decreased quality of life. These changes may persist even years after treatment and may affect both well-being and recovery. It could therefore be suggested that metabolic flexibility in muscle fibers in patients with TNBC may be reduced, particularly in patients undergoing systemic treatment, with potential difficulties adapting to different intensities and energy demands in daily life. A decrease in muscle metabolic flexibility would also imply a reduction in muscle strength and physical function, significantly impairing quality of life. Therefore, the main objective of this study is to analyze muscle metabolic flexibility at different stages of early disease and to evaluate whether different types of exercise training can improve these outcomes. To achieve this, assessments will be conducted at four time points during the early stages of the disease: at diagnosis, after neoadjuvant treatment, after surgery, and following an exercise intervention. The assessments will include blood analyses, body composition measurements, cycling exercise tests to evaluate oxygen consumption and the utilization of fat and glucose, measurements of muscle strength, and questionnaires assessing fatigue and quality of life. After surgery, participants will be randomly assigned to one of four groups for 12 weeks: a control group receiving general physical activity recommendations; a moderate-intensity cardiovascular exercise group focused on maximal fat oxidation; a high-intensity interval cardiovascular exercise group; and a progressive resistance training group. The final objective is to determine which type of exercise most effectively improves metabolic flexibility, muscle strength, body composition, and overall well-being. Participation in the study is voluntary and does not affect standard medical care. All assessments and training sessions will be supervised by qualified exercise professionals to ensure participant safety.

Conditions

Triple-Negative Breast Cancer (TNBC)

Keywords

Triple-Negative Breast Cancer; Metabolic Flexibility; Mitocondrial disfunction; Maximal Fat Oxidation; Exercise Intervention; Cardiovascular Training; Resistance Training

Outcome Measures

Primary Outcomes (5)

• Respiratory Exchange Ratio (RER)

  The respiratory exchange ratio is the ratio of carbon dioxide production (VCO2) to oxygen consumption (VO2) measured during respiration. It is obtained through indirect calorimetry during rest or exercise and reflects substrate utilization (fat or carbohydrate oxidation).

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Fat Oxidation (FATox)

  Fat oxidation refers to the rate at which fatty acids are used as an energy substrate by the body during rest or exercise. It is typically estimated from oxygen consumption (VO2) and carbon dioxide production (VCO2) using indirect calorimetry. FATox is commonly expressed in grams per minute (g/min).

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Carbohydrate Oxidation (CHOox)

  Carbohydrate oxidation refers to the rate at which carbohydrates are metabolized to produce energy during rest or physical exercise. It is estimated using oxygen consumption (VO2) and carbon dioxide production (VCO2) measured through indirect calorimetry. CHOox is typically expressed in grams per minute (g/min).

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Energy Expenditure

  This variable represents the amount of energy derived from fat and CHO oxidation during rest or exercise. It is estimated using oxygen consumption (VO2) and carbon dioxide production (VCO2) obtained through indirect calorimetry. Energy expenditure is typically expressed in kilocalories (kcal).

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Lactate Concentration

  Lactate concentration represents the amount of lactate present in the blood during rest or exercise. It is measured using the Lactate Plus device through capillary puncture of the middle or ring finger of the non-dominant hand and is expressed in millimoles per liter (mmol/L). This variable provides information about anaerobic metabolism and exercise intensity.

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

Secondary Outcomes (34)

• Resting Energy Expenditure (REE)

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Power

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Maximal Oxygen Consumption (VO2máx)

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Ventilatory Volume (VE)

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

• Oxygen Consumption (VO2)

  1 week after diagnosis (baseline); 1 week after completion of neoadjuvant treatment; 4 weeks after breast surgery or upon surgeon approval; and 1 week after completion of the exercise intervention or control period.

Study Arms (4)

Control group

NO INTERVENTION

Receives the general physical activity recommendations from the WHO

Cardiovascular training group at maximal fat oxidation (FATmax)

EXPERIMENTAL

Group performing cardiovascular training at maximal fat oxidation (FATmax) through continuous training on a stationary bicycle at a low-to-moderate intensity. There will be a progressive increase in the number of minutes throughout the intervention.

Other: Cardiovascular training at maximal fat oxidation (FATmax)

Cardiovascular training group at maximal aerobic power (MAP)

EXPERIMENTAL

Group performing cardiovascular training at maximal aerobic power (MAP) through high-intensity interval training on a stationary bicycle. There will be a progressive increase in the minutes performed at MAP throughout the intervention

Other: Cardiovascular training at maximal aerobic power (MAP)

Resistance training group

EXPERIMENTAL

Participants in resistance training group will follow a 12-week strength training program with progressive loads, twice a week. The intervention in this group will be based on the key training principles in the field of health: the principle of individualization, the principle of supercompensation, and the principle of specificity. There will be a two-week familiarization period that will take into account the patient's initial level, starting with moderate loads to reach high loads up to 1 repetition in reserve (RIR 1) by the end of the intervention.

Other: Resistance training

Interventions

Cardiovascular training at maximal fat oxidation (FATmax) OTHER

Group performing cardiovascular training at maximal fat oxidation (FATmax) twice per week for 12 weeks

Cardiovascular training group at maximal fat oxidation (FATmax)

Cardiovascular training at maximal aerobic power (MAP) OTHER

Group performing cardiovascular training at maximal aerobic power (MAP) twice per week for 12 weeks

Cardiovascular training group at maximal aerobic power (MAP)

Resistance training OTHER

Group performing progressive resistance training twice per week for 12 weeks

Resistance training group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female between 20-55 years of age.
• Confirmed histological new diagnosis of stage I to III triple-negative breast cancer and a candidate to receive systemic neoadjuvant treatment with chemotherapy +/- immunotherapy.
• Must not have started systemic treatment for the neoplastic disease.
• Participating in any external physical exercise program or sports activities during the experimental study phase.
• Inability to understand and provide written Informed Consent (IC)

You may not qualify if:

• Having neurological or orthopedic disease at the time of recruitment or during the study evaluation and intervention.
• Inability to understand Spanish language.
• Presenting absolute contraindications for performing a cardiopulmonary exercise test (CPET) such as heart failure, myocarditis, acute pericarditis, severe aortic stenosis, aortic dissection, vascular toxicity, uncontrolled severe arterial hypertension, uncontrolled severe cardiac arrhythmias, pulmonary thromboembolism, or severe anemia.
• Have relative contraindications for performing a CPET such as bradyarrhythmias or tachyarrhythmias, moderate valvular stenosis, inability to perform physical or mental exertion, chronic infectious diseases, musculoskeletal disabilities, ventricular aneurysm, second- or third-degree atrioventricular block, or severe arterial hypertension.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• European University of Madrid: collaborator
• Hospital Universitario Severo Ochoa: collaborator
• Hospital Universitario Infanta Leonor: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator

Study Sites (1)

Universidad Europea de Madrid, Villaviciosa de Odón

Madrid, Madrid, 28670, Spain

Location

Related Publications (76)

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MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brea Lidia, Profesor titular UEM

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 20, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

ES (1)