Exercise for the Treatment of Cancer-Related Sarcopenia

NCT07498985 | Not Yet Recruiting

• 1 other identifier: PBA2025201000211
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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 fatigue, and sleep quality. Additionally, we will explore the effects of exercise on bone and fat mass as secondary outcomes.

Conditions

Cancer; Sarcopenia

Keywords

muscle loss; Frail; Resistance Training

Outcome Measures

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).

  baseline, week 24 (post exercise)

Secondary Outcomes (9)

• Body composition

  Baseline and week 24 (post exercise intervention)

• Cardiorespiratory endurance and functional capacity

  Baseline and week 24 (post exercise intervention)

• Fatigue

  Baseline and week 24 (post exercise intervention)

• Health-related quality of life (HRQOL)

  Baseline and week 24 (post exercise intervention)

• Blood markers

  Baseline and week 24 (post exercise intervention)

Study Arms (2)

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.

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.

Interventions

Multimodal, supervised exercise training OTHER

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.

Exercise intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on biological sex characteristics relevant to breast and gynecological cancers, as these conditions depend on the presence of specific tissues and treatments that may influence the study outcomes. Gender identity is respected and recorded but does not override the biological criteria required for study eligibility.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of Londrina: lead

Study Sites (1)

State University of Londrina

Londrina, Paraná, 86047-597, Brazil

Location

MeSH Terms

Conditions

Neoplasms; Sarcopenia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Rafael Deminice, PhD

CONTACT

+5543991916013; rdeminice@uel.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators were not blinded to group assignment, given the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

BR (1)