Exercise for the Treatment of Cancer-Related Sarcopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal, supervised exercise training.
- Who it may be relevant to
- Registry conditions: Cancer, Sarcopenia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exercise for the Treatment of Cancer-Related Sarcopenia: a Randomised Controlled Trial.
Overview
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.
Interventions
- Other Multimodal, supervised exercise training
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 stat
Primary outcome measures
- sarcopenia [Time frame: baseline, week 24 (post exercise)]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- > 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- State University of Londrina — Londrina
Identifiers
NCT: NCT07498985 · PBA2025201000211 · PBA2025201000211