The Relationships of Resistance Exercise, Walking, Myokine Secretion, Sarcopenia, Muscle Loss, Quality of Life, and Predictors in Cancer Patients Receiving Chemoradiotheray

January 11, 2024 updated by: Taipei Medical University
Cancer is the first most common cause of death in Taiwan. The application of surgery and chemoradiotherapy are used for treatment of patients with cancer. However, loss of muscle mass, low muscle strength, low physical performance, and sarcopenia are induced during chemoradiotherapy, consequently increased the risk of hematological toxicity and nonhematological toxicity, decreased quality of life and survival rate. It was reported that skeletal muscle can secretion of myokines, which contribute to muscle synthesis, growth, repair, or atrophy. Investigators suggest that detection of blood concentration of myokines and sarcopenia-related predictors can early detection potential individuals who are susceptibility to sarcopenia in cervical cancer patients receiving chemoradiotherapy. Also, resistance exercise was demonstrated to improve muscle mass, muscle strength, physical performance, and sarcopenia. Investigators suggest that resistance exercise can prevent cervical cancer patients from sarcopenia and improve quality of life through regulation the concentration of myokines. However, there was no study has been investigated their relationships. Therefore, investigators will conduct a randomized controlled trial study to estimate (1) the effect of resistance exercise, walking on regulation myokine secretion, improving skeletal muscle mass, muscle strength, physical performance, sarcopenia, and quality of life in cancer receiving chemoradiotherapy; (2) myokine level, muscle mass, muscle strength, physical performance, and sarcopenia incidence in cancer patients before and after receiving chemoradiotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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 is the first most common cause of death in Taiwan. The application of surgery and chemoradiotherapy are used for treatment of patients with cancer. However, loss of muscle mass, low muscle strength, low physical performance, and sarcopenia are induced during chemoradiotherapy, consequently increased the risk of hematological toxicity and nonhematological toxicity, decreased quality of life and survival rate. It was reported that skeletal muscle can secretion of myokines, which contribute to muscle synthesis, growth, repair, or atrophy. Investigators suggest that detection of blood concentration of myokines and sarcopenia-related predictors can early detection potential individuals who are susceptibility to sarcopenia in cervical cancer patients receiving chemoradiotherapy. Also, resistance exercise was demonstrated to improve muscle mass, muscle strength, physical performance, and sarcopenia. Investigators suggest that resistance exercise can prevent cervical cancer patients from sarcopenia and improve quality of life through regulation the concentration of myokines. However, there was no study has been investigated their relationships. Therefore, investigators will conduct a randomized controlled trial study to estimate (1) the effect of resistance exercise, walking on regulation myokine secretion, improving skeletal muscle mass, muscle strength, physical performance, sarcopenia, and quality of life in cancer receiving chemoradiotherapy; (2) myokine level, muscle mass, muscle strength, physical performance, and sarcopenia incidence in cancer patients before and after receiving chemoradiotherapy.

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.
96

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.

Study Contact Backup

Study Locations

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:

  • Cancer patients receiving chemoradiotherap
  • age 20-70 years old
  • participants who are available for doing resistance exercise and/or walking after physical assessment by physician
  • education level >=elementary school

Exclusion Criteria:

  • Participants can't speak Mandarin, Taiwanese, or Hakka language.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
No Intervention: control group
No exercise intervention measures will be implemented. The patient will carry out daily life according to his past living habits and continue to be followed for at least one year.
Experimental: resistance exercise group
Resistance exercise training begins before the patient undergoes concurrent chemoradiotherapy, radiotherapy, or chemotherapy. The patients were given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. After that, the patient is asked to regularly perform resistance exercise for at least 1 year.
Behavioral: resistance exercise and walking

After receiving the cases, they were divided into 4 groups by random allocation:

  1. Control group: No exercise intervention measures are performed, and the patients carry out their daily lives according to their past living habits.
  2. Resistance exercise group: Resistance exercise training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. The patients are given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. Afterwards, the patient is asked to regularly perform resistance exercise on his own for at least 1 year.
  3. Walking group: Walking training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. They should walk continuously for 15 minutes at least twice a day and continue walking at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walk
Experimental: walking group
Walking training begins before the patient undergoes simultaneous radiochemotherapy, radiation therapy, or chemotherapy, and requires continuous walking for 15 minutes at least twice a day and at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walking training. After that, ask the patient to walk regularly for at least 1 year.
Behavioral: resistance exercise and walking

After receiving the cases, they were divided into 4 groups by random allocation:

  1. Control group: No exercise intervention measures are performed, and the patients carry out their daily lives according to their past living habits.
  2. Resistance exercise group: Resistance exercise training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. The patients are given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. Afterwards, the patient is asked to regularly perform resistance exercise on his own for at least 1 year.
  3. Walking group: Walking training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. They should walk continuously for 15 minutes at least twice a day and continue walking at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walk
Experimental: resistance exercise and walking group
Before patients receive concurrent chemoradiotherapy, radiotherapy, or chemotherapy, they are given resistance exercise training and walking training for 12 consecutive weeks. After that, the patient is asked to regularly perform resistance exercise and walking for at least 1 year.
Behavioral: resistance exercise and walking

After receiving the cases, they were divided into 4 groups by random allocation:

  1. Control group: No exercise intervention measures are performed, and the patients carry out their daily lives according to their past living habits.
  2. Resistance exercise group: Resistance exercise training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. The patients are given resistance exercise training for 45 minutes each time, 3 times a week, for 12 consecutive weeks. Afterwards, the patient is asked to regularly perform resistance exercise on his own for at least 1 year.
  3. Walking group: Walking training begins before the patients receive simultaneous radiochemotherapy, radiation therapy, or chemotherapy. They should walk continuously for 15 minutes at least twice a day and continue walking at least 5 days a week. Or walk for at least 150 minutes a week and walk for at least 15 minutes continuously each time for 12 consecutive weeks of walk

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
physical functional performance
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
This study plans to use the 5-time stand-up-sit test to assess physical functional performance. Five stand-up and sit-down tests lasting more than or equal to 12 seconds indicate that the patient's physical function performance is reduced.During the measurement, the patient is asked to sit on a chair about 40cm above the ground. The back of the chair is against the wall. The patient is asked to sit down against the back of the chair. The patient is asked to stand up. The patient is asked to do his best to stand up and stand upright five times continuously and without interruption. Sit down, keeping your hands folded on your chest.During the test, the patient stood up once and was asked to count the sounds. The test ended when the patient stood up for the fifth time.
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
muscle strength
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
Measuring the patient's muscle strength with a handgrip dynamometer(Hand Grip Strength, EH101, CAMYR, Guangdong)
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
muscle mass
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
In order to avoid radiation exposure when patients undergo testing and to facilitate repeated measurements, this research plan will use the Bioelectrical Impedance Analyzer (BIA) Inbody S10 to detect the skeletal muscle mass of the limbs of patients. The bioelectrical impedance analyzer is currently a commonly used analyzer for clinical measurement of body composition, using microcurrent to measure the human body.
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
the incidence of sarcopenia
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.

The assessment of sarcopenia in this study uses the Asian Working Group for Sarcopenia (AWGS) diagnostic criteria as the criteria for screening sarcopenia, including: (1) low muscle strength: handgrip strength <28 kg for men, women <18 kg; (2) low physical performance: 5 stand-up and sit-down tests greater than or equal to 12 seconds; (3) loss of appendicular skeletal muscle mass (ASM): bioelectrical impedance analysis (BIA) men <7.0kg/m2, women <5.7kg/m2.

If the skeletal muscle mass of the limbs is reduced combined with weakened muscle strength or physical functional performance, it is called sarcopenia; if the skeletal muscle mass of the limbs is reduced, the muscle strength is weakened, and the physical functional performance is reduced at the same time, it is severe sarcopenia.
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
effectively improve their quality of life
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
This study uses the Functional Assessment of Cancer Therapy-General (FACT-G) to assess the quality of life of patients.
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.
The concentration of muscle hormones in the blood of cancer patients undergoing treatment
Time Frame: From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.

The specimen is collected based on the principle of collecting 5 mL of venous blood. The blood is injected into a special biochemical test tube containing Lithium heparin, an anticoagulant, and mixed gently to avoid blood coagulation and hemolysis.

Centrifuge at 3500 rpm for 10 minutes, and separate the upper plasma for detection of muscle hormones in the blood, including: myonectin, irisin, decorin, fibroblast growth factor-21, interleukin-15, interleukin-6, myostatin, osteonectin, and brain-derived hormones.
From enrollment to the end of treatment at 12 weeks, then follow up for 1 year.

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.
Taipei Medical University

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 (Actual)

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.
December 2, 2021

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.
September 30, 2024

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.
September 30, 2024

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).
December 18, 2023

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.
January 11, 2024

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.
January 12, 2024

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.
January 12, 2024

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.
January 11, 2024

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.
December 1, 2023

More Information

Terms related to this study

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.
  • N202109030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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