Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2019-10-17
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Treatment group
Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21days each cycle, and use 2 cycles
Fufang E'Jiao Jiang
Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
control group
Placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
placebo containing low-dose fufang E'Jiao Jiang
placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Interventions
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Fufang E'Jiao Jiang
Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
placebo containing low-dose fufang E'Jiao Jiang
placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients that pathologically diagnosed with colorectal cancer, non-small cell lung cancer (NSCLC) or gastric cancer.
3. The patients' TNM stage of NSCLC is IIIB-IV, colorectal cancer is IV, and gastric cancer is IV, in addition all of them should be with tumors that can not be radically resected.
4. If patients have not received chemotherapy, they should be evaluated that tumor will not progress within 30 days, and their bodies can tolerate intravenous targeted therapy.
5. Patients who meet the diagnostic criterion for cancer related fatigue with deficiency of qi and blood.
6. The expected survival period is more than 3 months.
7. Fatigue score evaluated by visual analogue fatigue scale isn't lower than 4, and Karnofsky scale score isn't lower than 60.
8. Good compliance and agreeable to sign an informed consent before test.
9. Subjects agree not to participate in other intervention studies during test.
Exclusion Criteria
2. Those who have significant trauma injuries in the past one month.
3. Those who have severe bleeding or systemic infection diseases that had not been completely controlled.
4. Those who have tangible proofs of marrow or central nervous system metastasis.
5. Those who have received erythropoietin or blood transfusion within 1 month before test.
6. Those who have hypersplenism, hyperthyroidism, desmosis, tuberculosis and other diseases that have not been completely controlled.
7. Those who complicated with serious diseases such as cardiovascular or cerebrovascular system diseases, active hepatitis, disfunction of liver or kidney.
8. Those who are known or suspected to be allergic to test drugs.
9. Those who have eaten EJiao products in the past 2 weeks.
10. Those who have occurred Ileus.
11. Those suffering from severe malabsorption or other diseases that affect gastrointestinal absorption.
12. Those who cannot understand, read and fill in the self-rating scale due to their level of knowledge or intelligence.
13. Those who may happen any unstable conditions or conditions that endanger the patient's safety or compliance, for example the spirits.
14. Those who have been diagnosed with other malignant tumors (except fully treated cervix and skin carcinoma in situ, or other tumors that have been surgically cured and not recurred for at least 5 years) .
15. Those who participated in other therapeutic clinical trials within 30 days.
16. Pregnant or nursing women, or childbearing female that are inadequate contraception.
17. Those who are inappropriate to participate in the study determined by investigators.
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Shandong University of Traditional Chinese Medicine
OTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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xu yun, doctor
Role: STUDY_DIRECTOR
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Locations
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Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Song Z, Sun LY, Gu SS, Zhu XS, Lai HZ, Lu F, Cui N, Li QY, Wu Y, Xu Y. Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E'jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211002919. doi: 10.1177/15347354211002919.
Other Identifiers
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2018YFC1707406
Identifier Type: -
Identifier Source: org_study_id
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