Fufang E'Jiao Jiang Intervening Cancer-related Fatigue

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    600
  • sponsor
    Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Updated on 24 January 2021
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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 medicineTCM 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.

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 medicineTCM in the treatment of CRF and support some high quality, internationally recognized clinical evidence.

Details
Condition Cancer Related Fatigue
Treatment Fufang E'Jiao Jiang, placebo containing low-dose fufang E'Jiao Jiang
Clinical Study IdentifierNCT04147312
SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
Last Modified on24 January 2021

Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Cancer Related Fatigue?
Do you have any of these conditions: Do you have Cancer Related Fatigue??
The age of patients between 18 and 75gender 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
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