Effect and Mechanism of TCM-TSKSR on Advanced Colon Cancer: A Randomized Placebo-Controlled Clinical Trial

Phase 3

• Conditions: Advanced Colon Cancer

• Registration Number: ITMCTR1900002315
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patient with pathological diagnosis of colon cancer,tumor-node-metastasis(TNM)Stage IV colon cancer according to 8th edition of American Joint Committee on Cancer(AJCC)Staging Manual;
(2) Receiving or plan to start chemotherapy of XELOX or XELIRI;
(3) Aged between 18 to 80 years male and female and signed informed consent.

Exclusion Criteria

1. History of previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin.
2. serious heart,liver or kidney dysfunction.
3. Those who cannot take the study drug orally because of bowel obstruction and/or require for peripheral vein nutrition;or malabsorption or diseases that affect the absorption;or active peptic ulcer disease.
4. Any unstable conditions or conditions that may endanger the safety of patients and their compliance with the study;
5. Patients who received any of the following treatments during a specified period prior to the research:
(1) received antibiotic treatment within 2 weeks;
(2) receiving intestinal flora regulator.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DCR;MD Anderson Symptom Inventory (MDASI) Score;

Secondary Outcome Measures

Name	Time	Method
Change of Kidney Deficiency Scale Score;Incidence of adverse effects(AEs);Change of Spleen Deficiency Scale Score;Edmonton Symptom Assessment Scale(ESAS) score;