Yiqi Chupi Powder for treating chemotherapy-related fatigue after colorectal cancer surgery:a multicenter randomized controlled trial

Phase 1

• Conditions: colorectal cancer; C18.951

• Registration Number: ITMCTR2200005712
• Lead Sponsor: Shanxi Province Hospital of Traditional Chinese Medicine

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.The pathological examination conforms to the diagnostic criteria of western medicine for colorectal cancer;
2.Postoperative stage of colorectal cancer is stage II with high-risk factors; or postoperative stage is stage III and requires postoperative adjuvant chemotherapy.
3.Comply with the diagnostic criteria of TCM syndrome of qi deficiency and kidney deficiency;
4.Age between 18-80 years old, no gender restrictions;
5.Liver and kidney function and hematopoietic function are basically normal(in the absence of ongoing supportive care):Neutrophils>1.5×109/L, platelets>100×109/L, hemoglobin>9.0g/dL; total bilirubin normal or <1.5×ULN; AST(SGOT), ALT(SGPT) <2.5×ULN ; Serum creatinine <1.5×ULN;
6.Expected survival = 6 months;
7.The score of KPS=60 points;
8.Signing the informed consent voluntarily .

Exclusion Criteria

1.Patients who have mental disorders (mental disorders or severe dementia);
2.Liver and kidney functions are abnormal(AST, ALT, TBIL values are higher than 2.5 times the upper limit of normal values or BUN, Cr values are higher than 2 times the upper limit of normal values), Cardiac enzyme abnormalities(CK or CK-MB values above the upper limit of normal); Blood routine is abnormal(WBC, HGB, PLT are lower than the normal);
3.The patients who combined with other serious circulatory system, hematopoietic system, digestive system, endocrine system and other diseases;
4.Those who refuse postoperative adjuvant chemotherapy;
5.Pregnant, breastfeeding and planning to become pregnant;
6.He people participated in other clinical research in the past 1 month.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Piper Fatigue Score;

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival;C reactive protein;Tumor markers;The score of troditional Chinese medicine syndrome;The score of Karnofsky;