Tai Chi exercise for treating colorectal cancer patients

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

This study is testing a special Tai Chi exercise program to see if it can help people with colorectal cancer improve their health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06104267 on ClinicalTrials.gov

What this trial studies

This study explores the Medical Tai Chi Exercise Healing System (MTCEH), which combines Tai Chi exercise with traditional Chinese mental and physical training methods to target colorectal cancer treatment. The approach aims to provide individualized treatment through easily learnable routines that integrate rehabilitation and sports medicine principles. Participants will engage in a 7-form Medical Tai Chi exercise specifically designed for colon cancer patients, with the goal of improving their health outcomes. The study is grounded in evidence-based medicine to enhance the effectiveness of traditional Tai Chi in cancer care.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with adenocarcinoma of the colon or rectum who have a performance status of 0-2 and meet specific health criteria.

Not a fit: Patients with other concurrent cancers or serious medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the quality of life and health outcomes for patients with colorectal cancer.

How similar studies have performed: While Tai Chi has shown health benefits in various contexts, this specific integration with cancer treatment is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Yanhong Gu

Conditions: Colorectal Cancer