NCT04692454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 16, 2020

Last Update Submit

December 29, 2020

Conditions

Keywords

gastrointestinalHepatocellularimmunosuppressionacupuncture

Outcome Measures

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.

    4 weeks

Study Arms (1)

the scalp and ear acupuncture

EXPERIMENTAL

CHIAN HUEI ACUPUNCTURE NEEDLE

Other: Modern acupuncture

Interventions

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 scalp and ear acupuncture

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFangH

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Liver NeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesGastrointestinal Diseases

Study Officials

  • Ming-Shun Wu, PHD

    Taipei Municipal Wanfang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of GI

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 31, 2020

Study Start

August 31, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations