A randomized, double-blind trial of efficacy and mechanism of Shiwei Yiyuan granules for cancer-related fatigue

Phase 1

Recruiting

• Conditions: cancer-related fatigue

• Registration Number: ITMCTR2100004481
• Lead Sponsor: Xiyuan Hospital of 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Pathologically confirmed primary lung cancer and colorectal cancer patients with measurable lesions can be evaluated for curative effect (Based on RECIST 1.1 therapeutic efficacy evaluation criteria for solid tumors);
2.meet the diagnostic criteria for cancer-related fatigue;
3. Fatigue Score >= 4.(The degree of fatigue was scored using a 0-10 numerical rating scale, 0 = no fatigue, 10 = most severe fatigue);
4. Patients who agree not to participate in other intervention studies during treatment;
5. Aged 18-80 years, regardless of gender;
6. The estimated survival time is greater than 3 months.

Exclusion Criteria

1. The patient who has severe bleeding or is systemically infected;
2. The patient who has a clear invasion of bone marrow metastases;
3. The patient who has received surgery, chemotherapy, radiotherapy, targeted therapy, immune or other anti-tumor therapy within 1 month;
4. The patient who has used of erythropoietin and blood transfusion in the past 1 month;
5. Patient with severe diseases of heart, liver, kidney and other systems;
6. Pregnant women, lactating women, unconscious patients or patient who is unable to understand and participate in this study;
7. As determined by the researcher, patient is not suitable to participate in this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Piper fatigue Survey Scale;

Secondary Outcome Measures

Name	Time	Method
T lymphocyte and B lymphocyte;karnofsky performance score;blood routine examination;Symptom Inventory for TCM;