Medical Tai Chi Exercise Healing in Treating mCRC Patients

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: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanhong Gu; Phone Number: +8618915594572; Email: guluer@163.com
• Study Contact Backup: Name: Tianzhu Qiu; Email: tianzhu_qiu@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Contact: Yanhong Gu, Ph.D; Phone Number: 13813908678; Email: guluer@163.com
      • Principal Investigator: Yanhong Gu, Ph.D

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Adherence rates	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

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: SIR RUNRUN Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID 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