Medical Tai Chi Exercise Healing in Treating mCRC Patients

October 23, 2023 updated by: The First Affiliated Hospital with Nanjing Medical University

A Single-Arm, Prospective, Exploratory Study to Evaluate Feasibility and Effect of Medical Tai Chi Exercise Healing in Treating mCRC Patients

As a traditional martial art in China, Tai Chi Chuan has excellent health benefits along with its combat function.Studies have shown that Tai Chi as an exercise prescription can significantly reduce the incidence of cancer, but the complexity of Tai Chi Chuan routines, poor disease targeting, and the lack of traditional internal mental and physical training method limit the healing of tumours and other diseases. For this reason, we have established the Medical Tai Chi Exercise Healing System（MTCEH）, which integrates Tai Chi exercise, traditional Chinese internal mental and physical training method, rehabilitation medicine and sports medicine methods, on the basis of evidence-based medicine and with the aim of targeting different tumour treatments. With the characteristics of easily learning, internal and external training, and individualised treatment of tumours, this series of routines effectively combines traditional oriental Tai Chi martial arts with tumour treatment, which opens up a beautiful and mysterious oriental healing journey for integrative medicine.

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.

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.
30

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Yanhong Gu, Ph.D

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:

  1. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  3. Life expectancy of at least 6 months.
  4. Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol（ALT/AST≤2.5×UNL or ≤5×UNL with liver metastasis,TBIL≤2.5×UNL,Cr≤1.5×UNL,WBC≥3×109/L,NE≥1.5×109/L，PLT≥80×109/L，Hb≥90g/L,PT-INR/APTT <1.5UNL; LVEF≥ 50%）.
  5. Subjects must complete the treatment and follow-up on schedule according to the research plan.

Exclusion Criteria:

  1. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  2. Any serious or unstable medical condition、mental illness or known active alcohol or drug abuse or dependence.
  3. Unhealed surgical wounds and intolerance
  4. Extreme fatigue, anemia (<80 g/L) or dystaxia
  5. toxicity grade ≥III in chemoradiotherapy or targeted therapy (NCI-CTCAE 5.0), or severe intolerance
  6. exercise contraindications for patients with cardiovascular diseases or pulmonary diseases (referring to the Chinese Guideline for Cardiac Rehabilitation and Secondary Prevention [edition 2018] and Evidence-based Practice Guidelines for Clinical Rehabilitation of Chronic obstructive Pulmonary Disease [edition 2021]); uncontrolled unstable angina, diastolic dysfunction grade IV, uncontrolled severe arrhythmia, uncontrolled hypertension;
  7. high fever, serious infection, dyscrasia, multiple organ failure, or incapability to cooperate
  8. thrombosis in the active phase
  9. For female subjects: they should be surgical sterilized, postmenopausal patients, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period; The serum or urine pregnancy test must be negative within 7 days before enrollment and must be non lactating. Male subjects: patients who agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
  10. other conditions confirmed by the multidisciplinary cancer rehabilitation team.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Medical Tai Chi Exercise Group
Behavioral: 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients
The programme is based on the "7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients" that lasted 60 minutes three times a week for eight weeks and is led by a Tai Chi instructor with more than 5 years of teaching experience. Each session included a warm-up, movement instruction, breathing techniques, and relaxation. To ensure that each participant is proficient in Tai Chi, they will take at least 2 sessions of 60-minute Tai Chi training before the start of the intervention, until they are able to perform all Tai Chi movements correctly and successfully, and record a video to be used in software for practice at home. The enrolled patients, Tai Chi instructors and relevant staff of the subject group set up a WeChat group, and the enrolled patients, outside of the prescribed practice time each week, can practice at home or outdoors by themselves. They can send the video of the practice to the WeChat group.

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
Adherence rates
Time Frame: post 8-week intervention
The adherence rates will be measured by the number of tai chi sessions performed divided by the total possible tai chi sessions
post 8-week intervention

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
Time Frame
the Brief Fatigue Inventory (BFI)
Time Frame: post 8-week intervention
post 8-week intervention
the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: post 8-week intervention
post 8-week intervention
EORTC - Quality of Life
Time Frame: post 8-week intervention
post 8-week intervention
self-rating anxiety scale（SAS）
Time Frame: post 8-week intervention
post 8-week intervention
self-rating depression scale（SDS）
Time Frame: post 8-week intervention
post 8-week intervention

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.
The First Affiliated Hospital with Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SIR RUNRUN Hospital

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.
September 1, 2023

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 1, 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.
December 31, 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).
October 23, 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.
October 23, 2023

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.
October 27, 2023

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.
October 27, 2023

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.
October 23, 2023

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.
October 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.
  • KEEP-G 10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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