Colorectal CancerNCT06104267
Medical Tai Chi Exercise Healing in Treating mCRC Patients
A study testing 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients in people with Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological documentation of adenocarcinoma of the colon or rectum.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy of at least 6 months.
- 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%）.
- Subjects must complete the treatment and follow-up on schedule according to the research plan.
Who cannot join
- 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)].
- Any serious or unstable medical condition、mental illness or known active alcohol or drug abuse or dependence.
- Unhealed surgical wounds and intolerance
- Extreme fatigue, anemia (<80 g/L) or dystaxia
- toxicity grade ≥III in chemoradiotherapy or targeted therapy (NCI-CTCAE 5.0), or severe intolerance
- 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;
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- high fever, serious infection, dyscrasia, multiple organ failure, or incapability to cooperate
- thrombosis in the active phase
- 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.
- other conditions confirmed by the multidisciplinary cancer rehabilitation team.
Trial locations and contacts
1 site in 1 country.
Tianzhu Qiu contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Yanhong Gu, Ph.D, 13813908678, guluer@163.com
Yanhong Gu, Ph.D
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-Form of Medical Tai Chi Exercise Healing for Colon cancer patientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Tai Chi Exercise Group | Experimental | Not described Receives: Behavioral: 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates
The adherence rates will be measured by the number of tai chi sessions performed divided by the total possible tai chi sessions
Measured: post 8-week intervention
Secondary outcomes (5)
the Brief Fatigue Inventory (BFI)
Measured: post 8-week intervention
the Pittsburgh Sleep Quality Index (PSQI)
Measured: post 8-week intervention
EORTC - Quality of Life
Measured: post 8-week intervention
self-rating anxiety scale（SAS）
Measured: post 8-week intervention
self-rating depression scale（SDS）
Measured: post 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- SIR RUNRUN Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104267
- Sponsor's protocol ID
- KEEP-G 10
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective, Exploratory Study to Evaluate Feasibility and Effect of Medical Tai Chi Exercise Healing in Treating mCRC Patients
- ClinicalTrials.gov ID
- NCT06104267
- Acronym / sponsor ID
- KEEP-G 10
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- SIR RUNRUN Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Tai Chi Exercise Group | Experimental | Behavioral: 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological documentation of adenocarcinoma of the colon or rectum.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy of at least 6 months.
- 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%）.
- Subjects must complete the treatment and follow-up on schedule according to the research plan.
Key exclusion criteria (10 listed)
- 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)].
- Any serious or unstable medical condition、mental illness or known active alcohol or drug abuse or dependence.
- Unhealed surgical wounds and intolerance
- Extreme fatigue, anemia (<80 g/L) or dystaxia
- toxicity grade ≥III in chemoradiotherapy or targeted therapy (NCI-CTCAE 5.0), or severe intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patientsThe 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. | Behavioural | Medical Tai Chi Exercise Group |
Primary outcome
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
5 secondary outcomes
the Brief Fatigue Inventory (BFI)
Time frame: post 8-week intervention
the Pittsburgh Sleep Quality Index (PSQI)
Time frame: post 8-week intervention
EORTC - Quality of Life
Time frame: post 8-week intervention
self-rating anxiety scale（SAS）
Time frame: post 8-week intervention
self-rating depression scale（SDS）
Time frame: post 8-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianzhu Qiu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients in people with Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Gu (+8618915594572, guluer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rates (time frame: post 8-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.