Exercise for the Treatment of Cancer-Related Sarcopenia (HERA)

March 24, 2026 updated by: State University of Londrina

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rafael Deminice, PhD
  • Phone Number: +5543991916013
  • Email: rdeminice@uel.br

Study Locations

  • Brazil
    • Paraná
      • Londrina, Paraná, Brazil, 86047-597
        • State University of Londrina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise intervention group
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
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.
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
baseline, week 24 (post exercise)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Baseline and week 24 (post exercise intervention)
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.
Baseline and week 24 (post exercise intervention)
Cardiorespiratory endurance and functional capacity
Time Frame: Baseline and week 24 (post exercise intervention)
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.
Baseline and week 24 (post exercise intervention)
Fatigue
Time Frame: Baseline and week 24 (post exercise intervention)
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.
Baseline and week 24 (post exercise intervention)
Health-related quality of life (HRQOL)
Time Frame: Baseline and week 24 (post exercise intervention)
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.
Baseline and week 24 (post exercise intervention)
Blood markers
Time Frame: Baseline and week 24 (post exercise intervention)
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.
Baseline and week 24 (post exercise intervention)
Disease progression
Time Frame: Up to 1 year after the 48-week intervention period
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
Up to 1 year after the 48-week intervention period
Survival
Time Frame: Up to 1 year after the 48-week intervention period
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
Up to 1 year after the 48-week intervention period
Safety and exercise program adherence
Time Frame: Baseline and week 24 (post exercise intervention)
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.
Baseline and week 24 (post exercise intervention)
Physical activity levels
Time Frame: Baseline
Physical activity levels is assessed using the Portuguese version of the International Physical Activity Questionnaire
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of Londrina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBA2025201000211 (Other Grant/Funding Number: Fundação Araucaria)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Multimodal, supervised exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings