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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
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with ovarian cancer and endometrial cancer (cancer patients treated with chemotherapy, radiotherapy, and surgery) can be included.
  • Breast cancer: Diagnosed by pathological diagnosis of biopsy, without chemotherapy or radiotherapy.
  • Colorectal cancer: Diagnosed by pathological diagnosis of slices, without chemotherapy or radiotherapy.

Exclusion Criteria:

  • Pregnant women
  • Minors under the age of 20.
  • Those who are currently using traditional Chinese medicine

Information from the National Library of Medicine

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


Contacts
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Contact: Hung-Rong NA Yen 04-22053366 ext 3005 hungrongyen@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Hung-Rong Yen    04-22053366 ext 3005    hungrongyen@gmail.com   
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Chair: China Medicine University China Medicine University
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04438564    
Other Study ID Numbers: CMUH108-REC1-113
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
Chinese Herbal Medicine, Immunity, T Cell, Dendritic Cell
Additional relevant MeSH terms:
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Endometrial Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders