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Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers

Primary Purpose

Hepatocellular Cancer, Gastrointestinal Cancer, Immunosuppression

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Modern acupuncture
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Cancer focused on measuring gastrointestinal, Hepatocellular, immunosuppression, acupuncture

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • WanFangH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the scalp and ear acupuncture

Arm Description

CHIAN HUEI ACUPUNCTURE NEEDLE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
December 29, 2020
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04692454
Brief Title
Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers
Official Title
Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer, Gastrointestinal Cancer, Immunosuppression
Keywords
gastrointestinal, Hepatocellular, immunosuppression, acupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the scalp and ear acupuncture
Arm Type
Experimental
Arm Description
CHIAN HUEI ACUPUNCTURE NEEDLE
Intervention Type
Other
Intervention Name(s)
Modern acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of CD8+ T
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, PHD
Organizational Affiliation
Taipei Municipal Wanfang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
WanFangH
City
Taipei
ZIP/Postal Code
116
Country
Taiwan

12. IPD Sharing Statement

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Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers

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