Immunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients

NCT04438564 | Unknown

• 1 other identifier: CMUH108-REC1-113
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer; Cancer of Ovary; Cancer of Endometrium

Keywords

Chinese Herbal Medicine, Immunity, T Cell, Dendritic Cell

Outcome Measures

Primary Outcomes (1)

• The IL-2, TNF-alpha and IFN-gamma expression by traditional Chinese medicine treatment on cancer patients

  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.

  one year

Study Arms (1)

cancer of breast, colorectal, ovarian and endometrial

OTHER

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

Interventions

Cases for patients diagnosed with breast cancer, colonrectal cancer, ovarian cancer and endometrial cancer OTHER

Diagnosis and acceptance of breast cancer, colon rectal cancer, ovarian cancer, and endometrial cancer by the clinical Western medicine team.

cancer of breast, colorectal, ovarian and endometrial

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• China Medicine University

  China Medicine University

  STUDY CHAIR

Central Study Contacts

Hung-Rong NA Yen

CONTACT

04-22053366; hungrongyen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 19, 2020
• Study Start: May 18, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

TW (1)