CClinicalTrials.gg
CompletedNCT04692454Updated Dec 31, 2020

Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers

An interventional study of Modern acupuncture in Hepatocellular Cancer, Gastrointestinal Cancer and Immunosuppression, sponsored by Taipei Medical University WanFang Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-12-31.

Sponsored by Taipei Medical University WanFang Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2020, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Hepatocellular Cancer
  • Gastrointestinal Cancer
  • Immunosuppression

Keywords

  • gastrointestinal
  • Hepatocellular
  • immunosuppression
  • acupuncture
03

In context

Gastrointestinal Neoplasms

779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.

This study's enrollment of 5 is below the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Taipei Medical University WanFang Hospital is the lead sponsor of 196 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of gastrointestinal cancer
  • Must have the will to receive acupuncture

Exclusion criteria

Exclusion Criteria:

  • Clinical diagnosis of Late cancer
  • History of having bad reflect in acupuncture
  • Coagulopathy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    the scalp and ear acupuncture

    CHIAN HUEI ACUPUNCTURE NEEDLE

    Other: Modern acupuncture

Interventions

  • OtherModern 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

07

Study locations

1 site
  • WanFangH
    Taipei, 116, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04692454
Lead sponsor
Taipei Medical University WanFang Hospital
Responsible party
Ming-Shun Wu (Director of GI, Taipei Medical University WanFang Hospital) — Principal investigator
First posted
Dec 31, 2020
Start date
Aug 31, 2020
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update
Dec 31, 2020

Study contacts

Ming-Shun Wu, PHD
study director · Taipei Municipal Wanfang Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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