Fufang E'Jiao Jiang Intervening Cancer-related Fatigue
FFEJJICRF
The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)
1 other identifier
interventional
600
1 country
1
Brief Summary
With the therapeutic tool of carcinoma increasing, life span extending, the solicitude for the patients'quality of life appear more important. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Our previous clinical experience have shown that traditional Chinese medicine（TCM） had a great effect on improving CRF, Several studies proven that its'mechanism were related to the regulation of immune function and endocrine hormones. Fufang E'Jiao Jiang (FFEJJICRF) is a commonly-used Chinese patent medicine and successfully marketed in China for many years, which are effective in improvement for TCM symptoms of deficiency with qi and blood. This proposal will investigate the effects of FFEJJICRF on CRF among non-small cell lung cancer, colorectal cancer, and gastric cancer, so as to find a new way for curing it in clinical.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2019
CompletedStudy Start
First participant enrolled
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 25, 2020
August 1, 2019
1.6 years
September 1, 2019
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue degree with the Piper fatigue scale (Piper)
Piper is composed of 24 questions assessing total CRF, as well as subscales of behavioral, affective, sensory, and cognitive/mood fatigue. Each question is cored from 0 to10 points, where a higher score indicates severe symptoms; 1 to 3 point is mild, 4 to 6 point is moderate, and 7 to 10 point is severe. Piper is taken at the baseline, 1 weeks, 3 weeks,4 weeks, and 6 weeks after treatment
6 weeks
Secondary Outcomes (11)
The occurrence of myelosuppression during chemotherapy
10 weeks
The amounts of leukocyte cells, hemoglobin and platelet in peripheral blood
10 weeks
Change of patients' living quality with the Edmonton symptom assessment scale(ESAS)
10 weeks
Change of patients' functional status with Karnofsky performance status (KPS)
10 weeks
Quality of Life with Functional assessment of cancer therapy-fatigue（FACT-F）
6 weeks
- +6 more secondary outcomes
Other Outcomes (3)
Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively
6 weeks
Percentage of patients who dropout by other adverse reactions caused by drugs
6 weeks
Collect costs of the whole observation period, and count the cost-effectiveness analysis based on the outcome of clinical study
6 weeks
Study Arms (2)
Treatment group
EXPERIMENTALFufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21days each cycle, and use 2 cycles
control group
PLACEBO COMPARATORPlacebo 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
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, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Eligibility Criteria
You may qualify if:
- The age of patients between 18 and 75，gender not limited.
- Patients that pathologically diagnosed with colorectal cancer, non-small cell lung cancer (NSCLC) or gastric cancer.
- 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.
- 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.
- Patients who meet the diagnostic criterion for cancer related fatigue with deficiency of qi and blood.
- The expected survival period is more than 3 months.
- Fatigue score evaluated by visual analogue fatigue scale isn't lower than 4, and Karnofsky scale score isn't lower than 60.
- Good compliance and agreeable to sign an informed consent before test.
- Subjects agree not to participate in other intervention studies during test.
You may not qualify if:
- Those who need immunotherapy or radiotherapy during the test.
- Those who have significant trauma injuries in the past one month.
- Those who have severe bleeding or systemic infection diseases that had not been completely controlled.
- Those who have tangible proofs of marrow or central nervous system metastasis.
- Those who have received erythropoietin or blood transfusion within 1 month before test.
- Those who have hypersplenism, hyperthyroidism, desmosis, tuberculosis and other diseases that have not been completely controlled.
- Those who complicated with serious diseases such as cardiovascular or cerebrovascular system diseases, active hepatitis, disfunction of liver or kidney.
- Those who are known or suspected to be allergic to test drugs.
- Those who have eaten EJiao products in the past 2 weeks.
- Those who have occurred Ileus.
- Those suffering from severe malabsorption or other diseases that affect gastrointestinal absorption.
- Those who cannot understand, read and fill in the self-rating scale due to their level of knowledge or intelligence.
- Those who may happen any unstable conditions or conditions that endanger the patient's safety or compliance, for example the spirits.
- 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) .
- Those who participated in other therapeutic clinical trials within 30 days.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091, China
Related Publications (1)
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.
PMID: 33834863DERIVED
Study Officials
- STUDY DIRECTOR
xu yun, doctor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2019
First Posted
November 1, 2019
Study Start
October 17, 2019
Primary Completion
May 31, 2021
Study Completion
December 31, 2021
Last Updated
February 25, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share