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| Name | Class |
|---|---|
| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
| Shandong University of Traditional Chinese Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21days each cycle, and use 2 cycles |
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| control group | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fufang E'Jiao Jiang | Drug | Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of myelosuppression during chemotherapy | 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. |
| 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 | Safety evaluation | 6 weeks |
| Percentage of patients who dropout by other adverse reactions caused by drugs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xu yun, doctor | Contact | 15210775378 | xyxiao78@163.com | |
| cui ning, doctor | Contact | 15652590697 | 809918686@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| xu yun, doctor | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100091 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33834863 | Derived | 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. |
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|
| placebo containing low-dose fufang E'Jiao Jiang | Drug | 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 |
|
|
| 10 weeks |
| The amounts of leukocyte cells, hemoglobin and platelet in peripheral blood | 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) | 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) | 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） | 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 | 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) | 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 | T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets | 6 weeks |
| T-Cell Cytokines | 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 | 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 | Thyroid hormones index | 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 | Evaluation of health economics | 6 weeks |