Exercise for the Treatment of Cancer-Related Sarcopenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorState University of Londrina
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Multimodal, supervised exercise training
Other interventionThe 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Exercise intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
baseline, week 24 (post exercise)Secondary outcomes
1
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.
Time frame
Baseline and week 24 (post exercise intervention)2
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.
Time frame
Baseline and week 24 (post exercise intervention)3
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.
Time frame
Baseline and week 24 (post exercise intervention)4
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.
Time frame
Baseline and week 24 (post exercise intervention)Sponsors and contacts
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Source ClinicalTrials.gov
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