Immunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients
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|ClinicalTrials.gov Identifier: NCT04438564|
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
The immune system is our body's defense mechanism, which helps us to resist foreign pathogens and cancer cells in the body. However, if the immune system is too weak, too strong, or unbalanced, it will be susceptible to get bacterial and viral infections, unable to fight cancer, or cause allergies, autoimmune and rheumatic diseases. At present, there is no good western medicine to strengthen immunity when the body is insufficient immunity. However, strong immunity causes autoimmune diseases and need to be treated by steroids and immunosuppressive agents. These drugs have limited efficacy and often have many side effects. In the clinical practice of traditional Chinese medicine, tonify qi, supplement blood and nourish yin are often used to enhance immunity. However, there is no clinical test to demonstrate the modulation of immune response after traditional Chinese medicine treatment.
In our preliminary study, the investigators identified that the basic immune response of cancer patients is weaker than healthy people by testing the level of IFN-r (promoting T cell activity, anti-tumor, anti-viral), TNF-a (promoting B cell proliferation, producing antibodies, anti-tumor, anti-viral) and IL-2 (regulate the proliferation and differentiation). Besides, some Chinese herbal extracts can significantly stimulate the immune response higher than the general average basic immunity of cancer patients. Further, we will use the stimulatory Chinese medicine extract to administer to cancer patients and examine the immune response of cancer patients after taking them. Therefore, this test can provide actual data on the basic immunity of healthy people or cancer patients and the modulation of immune response by traditional Chinese medicine treatment. This analysis platform provides patients to select the medicines that can enhance the immune response for individuals and analyze the changes of the immune response after conditioning with the candidate Chinese medicines. Therefore, this test could be applied clinically to validate the immunological regulation of Chinese herbal medicine as well as analyze the immunological modulation against different cancer by various Chinese herbal medicine.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Colorectal Cancer Cancer of Ovary Cancer of Endometrium||Other: Cases for patients diagnosed with breast cancer, colonrectal cancer, ovarian cancer and endometrial cancer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Immunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients|
|Actual Study Start Date :||May 18, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
cancer of breast, colorectal, ovarian and endometrial
Patient who diagnostic of Breast cancer, Colorectal cancer, cancer of Ovary, and cancer of Endometrial are can recruit.
Other: Cases for patients diagnosed with breast cancer, colonrectal cancer, ovarian cancer and endometrial cancer
Diagnosis and acceptance of breast cancer, colon rectal cancer, ovarian cancer, and endometrial cancer by the clinical Western medicine team.
- The IL-2, TNF-alpha and IFN-gamma expression by traditional Chinese medicine treatment on cancer patients [ Time Frame: one year ]The cytokines expression of immune cells in the blood by traditional Chinese medicine treatment in breast cancer, colon-rectal cancer, ovarian cancer, and endometrial cancer will be investigated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438564
|Contact: Hung-Rong NA Yen||04-22053366 ext firstname.lastname@example.org|
|China Medical University Hospital||Recruiting|
|Contact: Hung-Rong Yen 04-22053366 ext 3005 email@example.com|
|Study Chair:||China Medicine University||China Medicine University|