Clinical trial NCT04692454: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Cancer
Gastrointestinal Cancer
Immunosuppression
Keywords: gastrointestinal
Hepatocellular
immunosuppression
acupuncture
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: The number of CD8+ T
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: WanFangH
Study officials:
affiliation: Taipei Municipal Wanfang Hospital
name: Ming-Shun Wu, PHD
role: STUDY_DIRECTOR
References: