Clinical trial NCT06104267: Medical Tai Chi Exercise Healing in Treating mCRC Patients
Official title: A Single-Arm, Prospective, Exploratory Study to Evaluate Feasibility and Effect of Medical Tai Chi Exercise Healing in Treating mCRC Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: SIR RUNRUN Hospital
First posted: 2023-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


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.

Primary outcomes:
measure: Adherence rates
timeFrame: post 8-week intervention
Secondary outcomes:
measure: the Brief Fatigue Inventory (BFI)
timeFrame: post 8-week intervention
measure: the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: post 8-week intervention
measure: EORTC - Quality of Life
timeFrame: post 8-week intervention
measure: self-rating anxiety scale（SAS）
timeFrame: post 8-week intervention
measure: self-rating depression scale（SDS）
timeFrame: post 8-week intervention
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References: