Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers

Gastrointestinal Cancer Clinical Trial

Official title:

Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692454
• Other study ID #: N202005058
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the total population of cancer patients, hepatocellular carcinoma (HCC) and colorectal cancer (CRC), two of gastroenterological cancers are involved in the most acquired five cancers. Colorectal cancer (CRC) is a leading cause of tumor-related morbidity and mortality worldwide, and HCC is one of the top ten cancers in China. Currently, the intervention for gastrointestinal cancers mainly focuses on surgical removal, but patients still have a high risk of recurrence. Thus, the prevention of cancer recurrence is the most crucial topic for the intervention. The pathophysiology of gastroenterological cancers is multifactorial and not yet completely understood. However, immunosuppression is a major contributing factor in tumor cells play a central part in disease progression. It determines the prognosis of patients.

Description:

According to the total population of cancer patients, hepatocellular carcinoma (HCC) and colorectal cancer (CRC), two of gastroenterological cancers are involved in the most acquired five cancers. Colorectal cancer (CRC) is a leading cause of tumor-related morbidity and mortality worldwide, and HCC is one of the top ten cancers in China. Currently, the intervention for gastrointestinal cancers mainly focuses on surgical removal, but patients still have a high risk of recurrence. Thus, the prevention of cancer recurrence is the most crucial topic for the intervention. The pathophysiology of gastroenterological cancers is multifactorial and not yet completely understood. However, immunosuppression is a major contributing factor in tumor cells play a central part in disease progression. It determines the prognosis of patients.

The immune checkpoint or complementary therapy in the course of cancer treatment has been reported as effective methods for patients. In recent years, more integrated treatment studies have found that acupuncture can improve the discomfort and pain caused by chemotherapy. In addition, the treatment of rheumatoid arthritis has shown that acupuncture can effectively regulate the immunity of patients. In this study, investigators are considering to apply modern acupuncture as the immune modulation in gastroenterological cancers. Modern acupuncture is to use the scalp and ear acupuncture methods to identify diseases and checkpoints and apply them to regulate the immune function of patients with gastroenterological cancers. The infiltration of a specific subtype of T-cell and the expression of PD-L1 in tumors may be applied as indicators of cancer prognosis. These CD8 T cells (also called Tex cells) often fail to eradicate tumors and can become dysfunctional or exhausted. The magnitude of the reinvigoration of circulating Tex cells determined in relation to pretreatment tumor burden correlated with clinical response. By monitoring Tex cells, investigators will evaluate the feasibility of acupuncture as a complementary therapy to regulate the immune functions of patients with gastroenterological cancers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of gastrointestinal cancer

• Must have the will to receive acupuncture

Exclusion Criteria:

• Clinical diagnosis of Late cancer

• History of having bad reflect in acupuncture

• Coagulopathy

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Hepatocellular Cancer
• Immunosuppression
• Liver Neoplasms

Intervention

Other:
• Modern acupuncture
use the scalp and ear acupuncture methods to identify diseases and checkpoints and apply them to regulate the immune function of patients with gastroenterological cancers.

Locations

Country	Name	City	State
Taiwan	WanFangH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of CD8+ T	Using PBMC to analyze the number of CD8+ T that is NK, NKT, DC, and Monocyte.; At the start of acupuncture adjuvant therapy (week 0, week 2, and week 4) blood was collected.; Blood draw - 15 ml/each; Week0- baseline, the original data of CD8+T before receiving acupuncture; Week2- the data of CD8+T after receiving acupuncture; Week4- the data of CD8+T after two weeks that the patients did not receive acupuncture; Compare with week0 and week2 data, if week2 data is higher than week0, it means the acupuncture has effective to add the number of CD8+ T.; Compare with week 2 and week 4 data results and confirm the data change of the number of CD8+ T after stopping the acupuncture. If the data do not decline, it means the effect of acupuncture remains to exist. If the data declines, it means the effect of acupuncture weakens.	4 weeks