- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04147312
Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (FFEJJICRF)
February 21, 2020 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences
The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
By conducting large sample, multicenter, double-blind, randomized comparison clinical research, this test will investigate the effects of fufang E'Jiao Jiang intervening cancer-related fatigue (CRF) with deficiency of qi and blood, under the guidance of its specification.
This test choose the improvement of fatigue degree as key indicator, and choose the improvement both symptoms of patients and quality of life as second indicators.
And last, the study will try to verify its safety and efficacy with some haematological indexs and reveal its mechanism from the perspectives of hormone, immune and metabonomics, so as to explore the advantages of traditional Chinese medicine(TCM) in the treatment of CRF and support some high quality, internationally recognized clinical evidence.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: xu yun, doctor
- Phone Number: 15210775378
- Email: xyxiao78@163.com
Study Contact Backup
- Name: cui ning, doctor
- Phone Number: 15652590697
- Email: 809918686@qq.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100091
- Recruiting
- Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences
-
Contact:
- Yu Wu, M.D.
- Phone Number: 86 10 62835438
- Email: wy713@vip.sina.com
-
Contact:
- Yun Xu, M.D.
- Phone Number: 8610 62835355
- Email: xyxiao78@163.com
-
Principal Investigator:
- zhuo song, doctoral student
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Pregnant or nursing women, or childbearing female that are inadequate contraception.
- Those who are inappropriate to participate in the study determined by investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Other Names:
|
Placebo Comparator: 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, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue degree with the Piper fatigue scale (Piper)
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The occurrence of myelosuppression during chemotherapy
Time Frame: 10 weeks
|
1)the duration time of myelosuppression; 2) the proportion among them that should be intervened with salvage treatments; the salvage treatments, including their variety, quantity and duration times; 3) the incidence and duration time of grade 3-4 myelosuppression.
Those measurements were recorded and calculated separately at the end of the study.
|
10 weeks
|
The amounts of leukocyte cells, hemoglobin and platelet in peripheral blood
Time Frame: 10 weeks
|
Those who are receiving chemotherapy should be measured at the baseline, 1 weeks, 3 weeks,4 weeks, 6 weeks and 10 weeks after treatment.
Those who are not receiving chemotherapy should be measured at the baseline, 3 weeks, 6 weeks, 10 weeks.
|
10 weeks
|
Change of patients' living quality with the Edmonton symptom assessment scale(ESAS)
Time Frame: 10 weeks
|
Changes of patients' living quality with ESAS to measure participants'responses to 11 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, feeling of well-being and pruritus).
Intensity of symptoms rated on a 0 to 10 scale from 0 "no symptom" to 10 "worst possible symptom"
|
10 weeks
|
Change of patients' functional status with Karnofsky performance status (KPS)
Time Frame: 10 weeks
|
KPS Scores ranged from 100 to 0,The higher score represent the better health, the more likely that you are able to tolerate the side effects of treatment.
It is generally considered that Karnofsky80 score or above represent patients can live independently, 60~80 score represent semi-independently, Under 60 represent patients often need help in living.
|
10 weeks
|
Quality of Life with Functional assessment of cancer therapy-fatigue(FACT-F)
Time Frame: 6 weeks
|
FACT-F investigates participants from six dimensions (physiology, social/family status, emotion, function, fatigue, tumor) and each question is rated on a 5-point Likert scale.
Higher scores represent more agreeable with the content of the items
|
6 weeks
|
Aldosterone, insulin-like growth factor, cortisol, growth hormone
Time Frame: 6 weeks
|
Levels of serum hormone on aldosterone, insulin-like growth factor, cortisol, growth hormone
|
6 weeks
|
Change from baseline in lymphocyte subsets counts up to 6 Weeks: T Cell, B Cell, Natural Killer Cell (T,B,NK)
Time Frame: 6 weeks
|
Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells
|
6 weeks
|
Change from baseline in T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets
Time Frame: 6 weeks
|
T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets
|
6 weeks
|
T-Cell Cytokines
Time Frame: 6 weeks
|
T-cell cytokine subsets include IFNγ, IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17A,IL-17F,IL-22,TNFα,TNFβ
|
6 weeks
|
Circulating metabolite concentrations by nontargeted metabolomics techniques
Time Frame: 6 weeks
|
Blood concentrations of metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins
|
6 weeks
|
Triiodothyronine, free triiodothyronine, bound thyroxine, free thyroxine, thyroid stimulating hormone
Time Frame: 6 weeks
|
Thyroid hormones index
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively
Time Frame: 6 weeks
|
Safety evaluation
|
6 weeks
|
Percentage of patients who dropout by other adverse reactions caused by drugs
Time Frame: 6 weeks
|
Another safety evaluation: Percentage of patients who dropout by other adverse reactions caused by drugs meanwhile excluding myelosuppression (grading standard of adverse reactions according to the evaluation standard of CTCAE v4.03)
|
6 weeks
|
Collect costs of the whole observation period, and count the cost-effectiveness analysis based on the outcome of clinical study
Time Frame: 6 weeks
|
Evaluation of health economics
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: xu yun, doctor, Xiyuan Hospital of China Academy of Chinese Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2019
Primary Completion (Anticipated)
May 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
September 1, 2019
First Submitted That Met QC Criteria
October 29, 2019
First Posted (Actual)
November 1, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018YFC1707406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer-related Fatigue
-
Buddhist Tzu Chi General HospitalRecruitingGynecologic Cancer | Cancer-related FatigueTaiwan
-
Taipei Medical UniversityNot yet recruitingCancer Related Fatigue
-
German Cancer Research CenterNational Center for Tumor Diseases, HeidelbergRecruitingCancer-related FatigueGermany
-
German Cancer Research CenterGerman Research Foundation; Wuerzburg University Hospital; Baden-Württemberg...RecruitingCancer-related FatigueGermany
-
PhytoHealth CorporationCompletedCancer-related FatigueTaiwan
-
German Cancer Research CenterActive, not recruitingCancer-related FatigueGermany
-
University of RochesterCompleted
-
Medice Arzneimittel Pütter GmbH & Co KGCompleted
-
Taichung Tzu Chi HospitalNot yet recruitingCancer-related Fatigue
-
University of CalgaryCanadian Cancer Society (CCS)Completed
Clinical Trials on Fufang E'Jiao Jiang
-
Zhong WangCompletedDanshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary DysmenorrheaPrimary Dysmenorrhea | Traditional Chinese MedicineChina
-
Beijing Friendship HospitalUnknown
-
Beijing 302 HospitalUnknown
-
Xiyuan Hospital of China Academy of Chinese Medical...UnknownNon-erosive Reflux Disease/Diarrheal Irritable Bowel SyndromeChina
-
University of Medicine and Pharmacy at Ho Chi Minh...CompletedCOVID-19 Respiratory Infection | Herbal MedicineVietnam
-
University of Medicine and Pharmacy at Ho Chi Minh...CompletedQuality of Life | COVID-19 PandemicVietnam
-
Zhong WangShanxi Zhendong pharmaceutical Co. LTD.CompletedAdverse Drug Events | Adverse Drug Reactions | Severe Adverse Events | Safety Surveillance | Severe Adverse ReactionsChina
-
DongE E Jiao Coporation LimitedNot yet recruiting
-
Institute of Medical Biology, Chinese Academy of...Hebei Provincial Center for Diseases Control and PreventionCompleted