Exercise for the Treatment of Cancer-Related Sarcopenia

N/ANot Yet RecruitingNCT07498985

State University of Londrina78 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cancer Sarcopenia

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

State University of Londrina

Londrina, Paraná, Brazil

Outcomes

Primary Outcomes

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

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)

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)

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.

Central Contacts

Rafael Deminice, PhD

CONTACT

+5543991916013 rdeminice@uel.br

Data from ClinicalTrials.gov

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