CancerHERANCT07498985
Exercise for the Treatment of Cancer-Related Sarcopenia
A study testing Multimodal, supervised exercise training in people with Cancer and Sarcopenia, run by State University of Londrina at 1 site in Brazil.
Trial summary
Our primary objective is to assess the effects of exercise on cancer-related sarcopenia and its hallmarks, including muscle strength, muscle mass, and physical performance. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (QoL), cancer-related… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Sarcopenia
- What is being tested?
- Multimodal, supervised exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- 1 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
- > 18 years old women with a confirmed diagnosis of breast or gynecological cancer.
- Any level of sarcopenia (pre-sarcopenia, sarcopenia, or severe sarcopenia).
- Patients must have completed their primary treatment regimen (surgery, chemotherapy, and/or radiotherapy) for at least 2 weeks and up to 2 years before enrolment.
- have received the medical consent to be engaged in physical exercise programs.
Who cannot join
- The presence of one or more comorbidities that could potentially interfere with attendance or test results (e.g., other cancers or acute or chronic renal failure);
- Already in exercise programs comparable to the HERA program;
- Evidence of severe cardiovascular disease as a result of an electrocardiogram.
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
State University of Londrina
Londrina, Paraná, 86047-597
Ivone Beraldo, +554333715953, cefepos@uel.br
About this study
Official title: Exercise for the Treatment of Cancer-Related Sarcopenia: a Randomised Controlled Trial.
Our primary objective is to assess the effects of exercise on cancer-related sarcopenia and its hallmarks, including muscle strength, muscle mass, and physical performance. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (QoL), cancer-related fatigue, and sleep quality. Additionally, we will explore the effects of exercise on bone and fat mass as secondary outcomes.
Read the detailed description
Cancer-related sarcopenia is a distinct and severe form of muscle atrophy, as no other condition (e.g., aging, immobilization, or microgravity) results in such profound impairment in patient prognosis. Sarcopenic cancer patients experience greater fatigue, poorer quality of life, longer hospital stays and higher costs, worse cancer outcomes, and increased mortality compared with non-sarcopenic patients. As no pharmacological treatments are approved for sarcopenia, management relies primarily on nutritional strategies and physical exercise. While exercise effectively prevents and attenuates sarcopenia in older adults, its efficacy in cancer patients remains uncertain.
Cancer-related sarcopenia is a multifactorial condition driven by tumor progression and cancer therapies. Tumors increase nutrient competition and promote hormonal dysregulation and chronic inflammation, impairing muscle protein balance. In addition, chemotherapy and radiotherapy induce oxidative stress and mitochondrial dysfunction, accelerating muscle wasting and contributing to anabolic resistance-a reduced responsiveness of muscle to stimuli such as exercise. These factors may limit exercise-induced gains in muscle mass and strength in cancer patients.
- Conditions
- Cancer, Sarcopenia
- Being tested
- Multimodal, supervised exercise training
- Keywords
- muscle loss, Frail, Resistance Training
- Medical subject headings
- Neoplasms, Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal, supervised exercise trainingOther
The multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting major upper and lower body muscle groups to improve muscle strength and mass. Six to eight exercises were performed using body weight, elastic bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the 0-10 Borg rating of perceived exertion when health status permitted. 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 intervention group | Experimental | The exercise group will be asked to complete 48 multicomponent, supervised exercise training sessions over 24 weeks, with a frequency of two sessions per week on non-consecutive days. Receives: Other: Multimodal, supervised exercise training |
| Control group | No intervention | Patients in the waiting list control group received standard medical care without any exercise program or specific exercise recommendations. To maintain contact with the researchers and minimize drop-out, the waiting list 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.
sarcopenia
Sarcopenia was determined using the revised European Consensus on Definition and Diagnosis of Sarcopenia [Cruz-Jentoft et al. 2019], with handgrip strength cut-offs adapted to the Brazilian population [Lima et al. 2025]. Any level of sarcopenia was considered to patients inclusion in the sarcopenic group, as follows: (i) pre-sarcopenia, low muscular strength (hand grip strength < 23 kg); (ii) sarcopenia, low muscular strength accompanied by low muscle mass (appendicular muscle mass < 15 kg); and severe sarcopenia, low muscular strength and low muscle mass accompanied by low physical performance assessed using the Short Physical Performance Battery (SPPB) score < 8).
Measured: baseline, week 24 (post exercise)
Secondary outcomes (9)
Body composition
Body composition was assessed using dual-energy X-ray absorptiometry (DXA) with a GE Lunar system (GE Healthcare, USA). Total and appendicular fat-free mass, fat mass, and bone mineral content were estimated from whole-body DXA scans, following the manufacturer's standard protocols. All scans were performed by a trained technician, and analyses were conducted using the manufacturer's software.
Measured: Baseline and week 24 (post exercise intervention)
Cardiorespiratory endurance and functional capacity
6MWT was also 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)
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)
Health-related quality of life (HRQOL)
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)
Blood markers
Plasma concentration of Cystatin C, creatinine, and C-reactive protein was determined after a 10 to 12 h fasted blood collection (8 ml). Blood was collected in the laboratory analysis sampling room and assessed for blood markers.
Measured: Baseline and week 24 (post exercise intervention)
Disease progression
Participants will be followed for disease progression for 1 year beyond the 48-month study period. Information on disease progression and (all-cause and breast cancer-specific) death is retrieved
Measured: Up to 1 year after the 48-week intervention period
Survival
Participants will be followed for survival for 1 year beyond the 48-month study period. Information on disease progression and (all-cause and breast cancer-specific) death is retrieved
Measured: Up to 1 year after the 48-week intervention period
Safety and exercise program adherence
Safety was monitored through systematic documentation of all serious events occurring during physical fitness testing or exercise sessions. Serious adverse events were defined as incidents necessitating suspension of the exercise program, such as falls with fractures, orthopedic injuries requiring hospitalization, or any event posing an immediate threat to life. Adherence was evaluated based on both participation in supervised exercise sessions and conformity with the prescribed exercise protocol. Attendance and exercise compliance for each scheduled session were recorded by the supervising trainer using a case report form.
Measured: Baseline and week 24 (post exercise intervention)
Physical activity levels
Physical activity levels is assessed using the Portuguese version of the International Physical Activity Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 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
- NCT07498985
- Sponsor's protocol ID
- PBA2025201000211
- Other IDs
- PBA2025201000211
- Acronym
- HERA
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for the Treatment of Cancer-Related Sarcopenia: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07498985
- Acronym / sponsor ID
- HERA / PBA2025201000211
- Conditions
- Cancer, Sarcopenia
- Keywords
- muscle loss, Frail, Resistance Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- State University of LondrinaUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Mar 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.
Our primary objective is to assess the effects of exercise on cancer-related sarcopenia and its hallmarks, including muscle strength, muscle mass, and physical performance. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (QoL), cancer-related fatigue, and sleep quality. Additionally, we will explore the effects of exercise on bone and fat mass as secondary outcomes.
Detailed description
Cancer-related sarcopenia is a distinct and severe form of muscle atrophy, as no other condition (e.g., aging, immobilization, or microgravity) results in such profound impairment in patient prognosis. Sarcopenic cancer patients experience greater fatigue, poorer quality of life, longer hospital stays and higher costs, worse cancer outcomes, and increased mortality compared with non-sarcopenic patients. As no pharmacological treatments are approved for sarcopenia, management relies primarily on nutritional strategies and physical exercise. While exercise effectively prevents and attenuates sarcopenia in older adults, its efficacy in cancer patients remains uncertain.
Cancer-related sarcopenia is a multifactorial condition driven by tumor progression and cancer therapies. Tumors increase nutrient competition and promote hormonal dysregulation and chronic inflammation, impairing muscle protein balance. In addition, chemotherapy and radiotherapy induce oxidative stress and mitochondrial dysfunction, accelerating muscle wasting and contributing to anabolic resistance-a reduced responsiveness of muscle to stimuli such as exercise. These factors may limit exercise-induced gains in muscle mass and strength in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention group | Experimental | Other: Multimodal, supervised exercise trainingThe exercise group will be asked to complete 48 multicomponent, supervised exercise training sessions over 24 weeks, with a frequency of two sessions per week on non-consecutive days. |
| Control group | No intervention | –Patients in the waiting list control group received standard medical care without any exercise program or specific exercise recommendations. To maintain contact with the researchers and minimize drop-out, the waiting list 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 (4 listed)
- > 18 years old women with a confirmed diagnosis of breast or gynecological cancer.
- Any level of sarcopenia (pre-sarcopenia, sarcopenia, or severe sarcopenia).
- Patients must have completed their primary treatment regimen (surgery, chemotherapy, and/or radiotherapy) for at least 2 weeks and up to 2 years before enrolment.
- have received the medical consent to be engaged in physical exercise programs.
Key exclusion criteria (3 listed)
- The presence of one or more comorbidities that could potentially interfere with attendance or test results (e.g., other cancers or acute or chronic renal failure);
- Already in exercise programs comparable to the HERA program;
- Evidence of severe cardiovascular disease as a result of an electrocardiogram.
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 |
|---|---|---|
| Multimodal, supervised exercise trainingThe multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting major upper and lower body muscle groups to improve muscle strength and mass. Six to eight exercises were performed using body weight, elastic bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the 0-10 Borg rating of perceived exertion when health status permitted. 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 intervention group |
Primary outcome
sarcopenia
Time frame: baseline, week 24 (post exercise)
Sarcopenia was determined using the revised European Consensus on Definition and Diagnosis of Sarcopenia [Cruz-Jentoft et al. 2019], with handgrip strength cut-offs adapted to the Brazilian population [Lima et al. 2025]. Any level of sarcopenia was considered to patients inclusion in the sarcopenic group, as follows: (i) pre-sarcopenia, low muscular strength (hand grip strength < 23 kg); (ii) sarcopenia, low muscular strength accompanied by low muscle mass (appendicular muscle mass < 15 kg); and severe sarcopenia, low muscular strength and low muscle mass accompanied by low physical performance assessed using the Short Physical Performance Battery (SPPB) score < 8).
9 secondary outcomes
Body composition
Time frame: Baseline and week 24 (post exercise intervention)
Cardiorespiratory endurance and functional capacity
Time frame: Baseline and week 24 (post exercise intervention)
Fatigue
Time frame: Baseline and week 24 (post exercise intervention)
Health-related quality of life (HRQOL)
Time frame: Baseline and week 24 (post exercise intervention)
Blood markers
Time frame: Baseline and week 24 (post exercise intervention)
Disease progression
Time frame: Up to 1 year after the 48-week intervention period
Survival
Time frame: Up to 1 year after the 48-week intervention period
Safety and exercise program adherence
Time frame: Baseline and week 24 (post exercise intervention)
Physical activity levels
Time frame: Baseline
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 27 Mar 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 Multimodal, supervised exercise training in people with Cancer and Sarcopenia, 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 4 inclusion and 3 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 27 Mar 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?
sarcopenia (time frame: baseline, week 24 (post exercise)). 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 27 Mar 2026.