CancerFITCANNCT07521826
Exercise Training in Women With Metastatic Breast Cancer
A study testing Exercise in people with Cancer and Metastases, run by State University of Londrina at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Metastases
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- Any other medical condition contraindicating participation in physical exercise;
- Conditions that impair adherence to study procedures or the ability to provide informed consent;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Estadual de Londrina, Londrina
Londrina, Paraná, 86047-597
Ivone Beraldo, +554333715953, cefepos@uel.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Metastases
- Being tested
- Exercise
- Keywords
- Low muscle strength, muscle loss, loss of physical function, cardiorespiratory fitness, multimodal exercise
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Other: Exercise |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Baseline and week 24 (post exercise intervention)
Secondary outcomes (3)
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.
Measured: 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.
Measured: Baseline and week 24 (post exercise intervention)
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.
Measured: Baseline and week 24 (post exercise intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521826
- Sponsor's protocol ID
- 6.766.609
- Acronym
- FITCAN
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Combined Exercise Training Program on Physical Function and Quality of Life in Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07521826
- Acronym / sponsor ID
- FITCAN / 6.766.609
- Conditions
- Cancer, Metastases
- Keywords
- Low muscle strength, muscle loss, loss of physical function, cardiorespiratory fitness, multimodal exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- State University of LondrinaUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: ExerciseThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | Exercise group |
Primary outcome
Cardiorespiratory endurance and functional capacity
Time frame: Baseline and week 24 (post exercise intervention)
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.
Lower-limb muscle strength
Time frame: Baseline and week 24 (post exercise intervention)
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
Handgrip strength
Time frame: Baseline and week 24 (post exercise intervention)
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
3 secondary outcomes
Body composition
Time frame: Baseline and week 24 (post exercise intervention)
Health-related quality of life
Time frame: Baseline and week 24 (post exercise intervention)
Fatigue
Time frame: Baseline and week 24 (post exercise intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. On reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cancer and Metastases, run by State University of Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Deminice, PhD (+5543991916013, rdeminice@uel.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory endurance and functional capacity (time frame: Baseline and week 24 (post exercise intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.