Last updated: October 23, 2023
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Colon Cancer
Colon Cancer; Rectal Cancer
Colorectal Cancer
Treatment
7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients
Clinical Study ID
NCT06104267
KEEP-G 10
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 laboratoryrequired by protocol(ALT/AST≤2.5×UNL or ≤5×UNL with livermetastasis,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 theresearch plan.
Exclusion
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary site or histology fromcolorectal cancer EXCEPT for curatively treated cervical cancer in situ, non-melanomaskin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma insitu) and T1 (tumor invades lamina propria)].
- Any serious or unstable medical condition、mental illness or known active alcohol ordrug 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), orsevere intolerance
- exercise contraindications for patients with cardiovascular diseases or pulmonarydiseases (referring to the Chinese Guideline for Cardiac Rehabilitation and SecondaryPrevention [edition 2018] and Evidence-based Practice Guidelines for ClinicalRehabilitation of Chronic obstructive Pulmonary Disease [edition 2021]); uncontrolledunstable angina, diastolic dysfunction grade IV, uncontrolled severe arrhythmia,uncontrolled hypertension;
- high fever, serious infection, dyscrasia, multiple organ failure, or incapability tocooperate
- thrombosis in the active phase
- For female subjects: they should be surgical sterilized, postmenopausal patients, oragree to use a medically approved contraceptive method during the study treatmentperiod and within 6 months after the end of the study treatment period; The serum orurine pregnancy test must be negative within 7 days before enrollment and must be nonlactating. Male subjects: patients who agree to use a medically approved contraceptivemethod during the study treatment period and within 6 months after the end of thestudy treatment period.
- other conditions confirmed by the multidisciplinary cancer rehabilitation team.
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: 7-Form of Medical Tai Chi Exercise Healing for Colon cancer patients
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
December 31, 2024
Connect with a study center
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu 210029
ChinaActive - Recruiting

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