Clinical trial NCT04147312: Fufang E'Jiao Jiang Intervening Cancer-related Fatigue
Official title: The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer-related Fatigue
Keywords: Traditional Chinese medicine
Fufang E'Jiao Jiang
Randomized controlled trial
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Shandong University of Traditional Chinese Medicine
First posted: 2019-11-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

1. The age of patients between 18 and 75，gender not limited.
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:

1. Those who need immunotherapy or radiotherapy during the test.
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.

Primary outcomes:
measure: Fatigue degree with the Piper fatigue scale (Piper)
timeFrame: 6 weeks
Secondary outcomes:
measure: The occurrence of myelosuppression during chemotherapy
timeFrame: 10 weeks
measure: The amounts of leukocyte cells, hemoglobin and platelet in peripheral blood
timeFrame: 10 weeks
measure: Change of patients' living quality with the Edmonton symptom assessment scale(ESAS)
timeFrame: 10 weeks
measure: Change of patients' functional status with Karnofsky performance status (KPS)
timeFrame: 10 weeks
measure: Quality of Life with Functional assessment of cancer therapy-fatigue（FACT-F）
timeFrame: 6 weeks
measure: Aldosterone, insulin-like growth factor, cortisol, growth hormone
timeFrame: 6 weeks
measure: Change from baseline in lymphocyte subsets counts up to 6 Weeks: T Cell, B Cell, Natural Killer Cell (T,B,NK)
timeFrame: 6 weeks
measure: Change from baseline in T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets
timeFrame: 6 weeks
measure: T-Cell Cytokines
timeFrame: 6 weeks
measure: Circulating metabolite concentrations by nontargeted metabolomics techniques
timeFrame: 6 weeks
measure: Triiodothyronine, free triiodothyronine, bound thyroxine, free thyroxine, thyroid stimulating hormone
timeFrame: 6 weeks
Other outcomes:
measure: Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively
timeFrame: 6 weeks
measure: Percentage of patients who dropout by other adverse reactions caused by drugs
timeFrame: 6 weeks
measure: Collect costs of the whole observation period, and count the cost-effectiveness analysis based on the outcome of clinical study
timeFrame: 6 weeks
Locations:
city: Beijing
country: China
facility: Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: xu yun, doctor
role: STUDY_DIRECTOR
References:
citation: 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.