Status:
UNKNOWN
Medical Tai Chi Exercise Healing in Treating mCRC Patients
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
SIR RUNRUN Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06104267
Start Date
September 1 2023
End Date
December 31 2024
Last Update
October 27 2023
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029