Effects of Danggui Buxue Decoction on Cancer-related Fatigue in Patients with Anemia Undergoing Chemotherapy after Colon Cancer Operation: A Randomized Controlled Trial
- Conditions
- Colon cancer
- Registration Number
- ITMCTR2200005659
- Lead Sponsor
- Fujian Provincial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria for colon cancer and CRF before the intervention
(2) Age 45-75 years old
(3) Patients with mild to moderate anemia (According to the NCI standard, the Hb < 100g /L
(4) Moderate to severe fatigue (with BFI-C score = 4) after cancer diagnosis due to cancer therapy or cancer itself
(5) After receiving the first course of postoperative chemotherapy, the surgical procedure is not limited except for colostomy, and chemotherapy options are not limited
(6) The patient has no mental illness, no communication barriers, and can independently complete the questionnaire survey
(7) Sign the informed consent form and participate in this study, with good compliance
(8) The KPS score is greater than 60 points
(1) Severe trauma, complicated and difficult major surgery or after intestinal stoma
(2) The spirit, intelligence, or thinking is abnormal and unable to cooperate
(3) Abnormal findings in a liver function test or a renal function test (aspartate aminotransferase or alanine aminotransferase = 2× upper normal range or creatinine = 2.0 mg/dL) or the presence of serious liver failure or renal failure
(4) Measures to relieve fatigue, such as cognitive behavioral therapy, psychosocial intervention, regular aerobic exercise (a regular moderate-intensity aerobic exercise time per week < 90 minutes)
(5) Those with obvious eating disorders, intestinal perforation, bleeding, and intestinal obstruction
(6) Abnormal findings in a thyroid function test (abnormal level of free thyroxine and thyroid stimulating hormone < 0.1 µIU/ml or TSH > 5.1µIU/ml
(7) History of medication (methylphenidate, modafinil, bupropion, dexamethasone) to manage cancerrelated fatigue taken within 4 weeks of the beginning of the trial
(8) Having participated in other clinical trials after the beginning of the trial
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EORTC QLQ-C30;The Chinese version of the Brief Fatigue Inventory (BFI-C);
- Secondary Outcome Measures
Name Time Method Adverse events;The Fuzhou version of the Montreal Cognitive Assessment (MoCA-fuzhou);Laboratory examination;TCM syndrome scores;