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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

96

Phase

  • 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 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

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
Intervention / Treatment
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

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

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)

December 2, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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