Multicenter Open-label Randomized Controlled Trial on treatment and safetyn for reshenguben oral liquid on Cancer-Related Fatigue

Phase 4

Recruiting

• Conditions: cancer-related fatigue

• Registration Number: ITMCTR2100004569
• Lead Sponsor: Shandong Cancer Hospital

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) Male or female between 18 and 80 years old;
(2) Tumor patients who have been diagnosed with cancer-related fatigue (the definition of cancer-related fatigue is based on the 2018 NCCN clinical practice guidelines for cancer-related fatigue);
(3) Ability to communicate fatigue levels with clinicians and fill out questionnaires independently;
(4) The BFI screening assessment score >= 4 points (the sum of the items contained in the total score divided by the total number of items, the score value is between 0-10 points) and at least continued 1 week;
(5) ECOG <= 3;
(6) Subjects voluntarily joined the study and signed an informed consent form.

Exclusion Criteria

(1) Past use of central nervous system stimulants or antidepressants or history of epilepsy;
(2) Those with suspected recurrence or progression of the disease through imaging examinations such as CT or X-ray;
(3) Hemoglobin < 80 g/L or platelets < 60 x 10^9/L or absolute value of neutrophils < 1.0 x 10^9/L;
(4) Patients with uncontrollable thyroid disease (free thyroxine > 1.79 ng/dL, thyroid-stimulating hormone > 10 um/dL);
(5) Pain cannot be controlled after applying analgesics;
(6) During the study period, take veratrum, wulingzhi, acacia or their preparations at the same time;
(7) Those who still have insomnia after receiving appropriate treatment;
(8) Combined cold;
(9) The investigator judges that surgery is needed during the study period;
(10) Patients with uncontrollable hypertension (DBP > 100 mmHg or SBP > 160 mmHg);
(11) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 3 ULN or active liver disease; blood creatinine> 2 ULN or undergoing renal dialysis treatment;
(12) Those who are allergic to the drugs used in this research;
(13) Mental and neurological disorders, who cannot express their wishes correctly;
(14) Pregnant women, lactating women and women of childbearing age who have not taken contraceptive measures;
(15) Patients currently participating in clinical trials of other drugs or medical devices;
(16) Those considered by the investigator to be unsuitable for inclusion.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Compared with baseline, the change in the BFI score at 6 weeks of treatment.;