Exercise Training in Women With Metastatic Breast Cancer (FITCAN)

Randomized Controlled Trial of a Combined Exercise Training Program on Physical Function and Quality of Life in Women With Metastatic Breast Cancer

The primary objective of the study is to evaluate the effects of exercise on physical function, physical fitness, and body composition, with the main components including muscular strength, cardiorespiratory fitness, muscle mass, fat mass, and fat-free mass. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (HRQoL), cancer-related fatigue, and sleep quality. Additionally, the feasibility and safety of the exercise program will be assessed.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Metastases
• Intervention / Treatment: Other: Exercise

Detailed Description

Historically, cancer patients, especially those in more advanced stages of the disease, were advised to maintain rest due to concerns about complications associated with tumor progression and the adverse effects of treatment. However, evidence accumulated over the past decades has demonstrated that physical inactivity may accelerate functional decline, reduce physical capacity, and impair quality of life in individuals with cancer. In this context, physical exercise has come to be recognized as an important strategy in cancer care. The regular practice of aerobic and resistance exercises has been associated with the reduction of treatment-related side effects, the preservation of physical function, and improvements in quality of life in different populations of cancer patients. In women with breast cancer, studies have shown that physical exercise can contribute to improvements in cardiorespiratory capacity, muscular strength, physical function, and quality of life, as well as help reduce cancer-related fatigue. However, most of the available evidence focuses on patients in the early stages of the disease or after primary treatment. In the case of women with metastatic breast cancer, scientific knowledge remains limited. Despite therapeutic advances that have increased survival in this population, these patients frequently experience functional decline, severe fatigue, loss of muscle mass and strength, and reduced quality of life. Furthermore, physical exercise is still rarely incorporated into the care of these patients, often due to uncertainties regarding the safety and effectiveness of such interventions. Although emerging evidence suggests that physical exercise may be safe and feasible for patients with metastatic disease, studies investigating structured and long-term exercise interventions in this population remain scarce. Therefore, further research is necessary to expand understanding of the effects of physical exercise in women with metastatic breast cancer, particularly focusing on physical function, physical fitness, body composition, and quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafael Deminice, PhD; Phone Number: +5543991916013; Email: rdeminice@uel.br

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86047-597
      • Universidade Estadual de Londrina, Londrina
      • Contact: Ivone Beraldo; Phone Number: +554333715953; Email: cefepos@uel.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged ≥ 18 years;
• Confirmed diagnosis of stage IV (metastatic) breast cancer;
• Currently undergoing medical treatment;
• Willingness and functional independence to participate in the exercise program;
• Medical clearance to engage in structured physical exercise.

Exclusion Criteria:

• Presence of unstable bone metastases.
• Untreated or symptomatic brain metastases;
• Evidence of severe cardiovascular disease identified by electrocardiogram (ECG);
• Severe active infection;
• Uncontrolled severe respiratory insufficiency or dependence on supplemental oxygen at rest or during exercise;
• Uncontrolled severe pain;
• Any other medical condition contraindicating participation in physical exercise;
• Conditions that impair adherence to study procedures or the ability to provide informed consent;
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; The exercise group will be instructed to complete 48 supervised, multicomponent physical training sessions over a 24-week period, with a frequency of two sessions per week on non-consecutive days.	Other: Exercise; The multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting the major muscle groups of the upper and lower body to improve strength and muscle mass. Six to eight exercises were performed using body weight, resistance bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the Borg 0-10 rating of perceived exertion scale, when health status allowed. The aerobic component consisted of walking, progressing to beginner-level running using short running intervals (50-100 m) interspersed with walking until longer continuous distances were achieved. Heart rate was monitored throughout the aerobic session.
No Intervention: Control group; Participants in the waitlist control group received standard medical care, without any exercise program or specific exercise recommendations. To maintain contact with the investigators and minimize study dropout, the waitlist control group received general health information through monthly online meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory endurance and functional capacity	6MWT was performed as a parameter of cardiorespiratory endurance and functional capacity. Participants were instructed to walk back and forth along a flat, straight 25m corridor for six minutes, covering as much distance as possible at a self-selected pace. The total distance walked (in meters) was recorded as the primary outcome.	Baseline and week 24 (post exercise intervention)
Lower-limb muscle strength	Lower-limb muscle strength was assessed using the five-repetition sit-to-stand test (5xSTS), according to the European Working Group on Sarcopenia in Older People (EWGSOP2)¹. Participants were instructed to stand up and sit down five times as quickly as possible, with their arms crossed over the chest. The total time to complete the test was recorded in seconds (s) and used as an indicator of muscle strength. All assessments were performed by a trained evaluator	Baseline and week 24 (post exercise intervention)
Handgrip strength	Muscle strength was assessed using a handgrip dynamometer (SH5001, Saehan Grip, South Korea). Participants performed three maximal voluntary contractions with each hand in an alternating sequence, with a one-minute rest interval between trials. The highest value (kg) achieved was used for analysis. All measurements wer	Baseline and week 24 (post exercise intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Fatigue was assessed using the Portuguese language version of the EORTC QLQ-FA12 [Weis et al. 2017]. The EORTC QLQ-FA12 is a 12-item questionnaire that assesses multiple dimensions of fatigue, including physical, emotional, cognitive, interference with daily activities, and social sequelae.	Baseline and week 24 (post exercise intervention)
Body composition	Body composition was assessed using tetrapolar bioelectrical impedance analysis (BIA) with the Analyxzer device. All assessments followed the manufacturer's standard protocols and were performed by a trained evaluator to ensure accuracy and reproducibility. Data analysis was conducted using the device-specific software. The following variables were obtained: total and appendicular fat-free mass, as well as fat mass. Results were expressed in absolute (kg) and relative (%) values.	Baseline and week 24 (post exercise intervention)
Health-related quality of life	Health-related quality of life (HRQOL) was assessed using the Portuguese language version of the EORTC QLQ-C30 [Aaronson et al. 1993]. The EORTC QLQ-C30 is a 30-item questionnaire comprising five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-item symptom measures (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for both instruments range from 0 to 100, with higher scores indicating greater symptom burden. The exception is the functional scales of the EORTC QLQ-C30, for which higher scores reflect better functional status.	Baseline and week 24 (post exercise intervention)

Collaborators and Investigators

• Sponsor: State University of Londrina

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cardiorespiratory fitness; muscle loss; multimodal exercise; Low muscle strength; loss of physical function
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Neoplastic Processes; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Neoplasm Metastasis; Muscular Atrophy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 6.766.609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No