Hepatocellular CancerNCT04692454
Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers
A study testing Modern acupuncture in people with Hepatocellular Cancer and Gastrointestinal Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatocellular Cancer, Gastrointestinal Cancer, Immunosuppression
- What is being tested?
- Modern acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of gastrointestinal cancer
- Must have the will to receive acupuncture
Who cannot join
- Clinical diagnosis of Late cancer
- History of having bad reflect in acupuncture
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Modern acupuncture
- Keywords
- gastrointestinal, Hepatocellular, immunosuppression, acupuncture
- Medical subject headings
- Liver Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modern acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| the scalp and ear acupuncture | Experimental | CHIAN HUEI ACUPUNCTURE NEEDLE Receives: Other: Modern acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start31 Aug 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Shun Wu, Taipei Medical University WanFang Hospital
- Investigators
- Ming-Shun Wu, PHD, Study director, Taipei Municipal Wanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692454
- Sponsor's protocol ID
- N202005058
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Immune Modulation by Modern Acupuncture in Gastroenterologic Cancers
- ClinicalTrials.gov ID
- NCT04692454
- Acronym / sponsor ID
- N202005058
- Keywords
- gastrointestinal, Hepatocellular, immunosuppression, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the scalp and ear acupuncture | Experimental | Other: Modern acupunctureCHIAN HUEI ACUPUNCTURE NEEDLE |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of gastrointestinal cancer
- Must have the will to receive acupuncture
Key exclusion criteria (3 listed)
- Clinical diagnosis of Late cancer
- History of having bad reflect in acupuncture
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modern acupunctureuse the scalp and ear acupuncture methods to identify diseases and checkpoints and apply them to regulate the immune function of patients with gastroenterological cancers. | Other | the scalp and ear acupuncture |
Primary outcome
The number of CD8+ T
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Shun Wu, PHD study director
Taipei Municipal Wanfang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modern acupuncture in people with Hepatocellular Cancer and Gastrointestinal Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of CD8+ T (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.