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Electroacupuncture intervention for gastrointestinal dysfunction after chemotherapy in colorectal cancer: a randomized controlled trial

Registration number：

ITMCTR2200006415

Date of Last Refreshed on：

2022-08-01

Date of Registration：

2022-08-01

Registration Status：

Prospective registration

Public title：

Electroacupuncture intervention for gastrointestinal dysfunction after chemotherapy in colorectal cancer: a randomized controlled trial

English Acronym：

Scientific title：

A randomized controlled trial on the effectiveness and safety of acupuncture in the treatment of gastrointestinal dysfunction after chemotherapy for colorectal cancer

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200062317 ; ChiMCTR2200006415

Applicant：

Xu Tao

Study leader：

Liang Fanrong

Applicant telephone：

+86 13980550713

Study leader's telephone：

+86 13608058216

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1094140890@qq.com

Study leader's E-mail：

acuresearch@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

37 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan

Study leader's address：

37 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Chengdu University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2021KL-079

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine

Date of approved by ethic committee：

2021/8/16 0:00:00

Contact Name of the ethic committee：

Wang Yanqiao

Contact Address of the ethic committee：

39 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Chengdu University of Traditional Chinese Medicine

Primary sponsor's address：

37 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan

Secondary sponsor：

Country：

China

Province：

Sichuan

City：

Chengdu

Institution
hospital：

Chengdu University of Traditional Chinese Medicine

Address：

37 Shi'erqiao Road, Jinniu District

Source(s) of funding：

Key Project of Sichuan Provincial Department of Science and Technology

Target disease：

Colorectal cancer

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To evaluate the efficacy and safety of acupuncture points in the treatment of gastrointestinal dysfunction after chemotherapy for colorectal cancer.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) The age is 18 years old ≤ age ≤ 75 years old, male or female; (2) The diagnosis of primary colon cancer or primary high rectal cancer was confirmed by colonoscopy and histopathological biopsy; (3) At least one cycle of chemotherapy has been completed, and symptoms related to gastrointestinal dysfunction, including nausea, vomiting, abdominal distension, diarrhea, constipation, etc., have been completed after chemotherapy; any item in the gastrointestinal symptom grading scale has a score of 2 or more . (4) Karnofsky score ≥ 60 points, or ECOG physical condition score ≤ 1 point; (5) Have not received acupuncture and moxibustion in the past 3 months and have not participated in other clinical investigators in the past 3 months; (6) Gastrointestinal dysfunction caused by non-opioid drugs or metabolic imbalance; (7) Sign the informed consent form and voluntarily participate in this researcher.

Exclusion criteria：

(1) Those who have undergone total colorectal resection; (2) Combined with severe heart and cerebrovascular diseases; (3) Combined with abnormal coagulation function; (4) Consciousness is unclear, unable to express subjective discomfort symptoms and mentally ill patients; (5) Long-term use of laxatives, or taking drugs that affect gastrointestinal function and long-term bed rest.

Study execute time：

From 2022-07-28

To      2023-12-31

Recruiting time：

From 2022-07-28

To      2023-12-31

Interventions：

77

Group：

Acupuncture group

Sample size：

Intervention：

Acupuncture

Intervention code：

77

Group：

Sham acupuncture group

Sample size：

Intervention：

Sham acupuncture

Intervention code：

77

Group：

Waiting list group

Sample size：

Intervention：

None

Intervention code：

Total sample size ： 231

Countries of recruitment
and research settings：

Country：

China

Province：

Yunnan

City：

Kunming

Institution/hospital：

Yunnan Cancer Hospital

Level of the institution：

tertiary first-class hospital

Country：

China

Province：

Henan

City：

Zhengzhou

Institution/hospital：

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Level of the institution：

tertiary first-class hospital

Country：

China

Province：

Hunan

City：

Changsha

Institution/hospital：

Changsha Traditional Chinese Medicine Hospital

Level of the institution：

tertiary first-class hospital

Country：

China

Province：

Henan

City：

Zhengzhou

Institution/hospital：

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Level of the institution：

tertiary first-class hospital

Country：

China

Province：

Sichuan

City：

Chengdu

Institution/hospital：

Chengdu University of Traditional Chinese Medicine

Level of the institution：

University

Country：

China

Province：

Henan

City：

Zhengzhou

Institution/hospital：

The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Level of the institution：

tertiary first-class hospital

Country：

China

Province：

Sichuan

City：

Chendu

Institution/hospital：

Sichuan Cancer Hospital

Level of the institution：

tertiary first-class hospital

Country：

China

Province：

Chongqing

City：

Chongqing

Institution/hospital：

Chongqing Traditional Chinese Medicine Hospital

Level of the institution：

tertiary first-class hospital

Country：

China

Province：

Henan

City：

Zhengzhou

Institution/hospital：

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Level of the institution：

tertiary first-class hospital

Outcomes：

Outcome：

Acupuncture Expectation Value Evaluation

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Patient Self-Reported Outcomes

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

SDS (Self-Rating Depression Scale)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

SAS (Self-Rating Anxiety Scale)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Evaluation of the Functional Assessment of Cancer Therapy-Colorectal (V4.0)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Treatment satisfaction evaluation

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Gastrointestinal symptom rating scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

excrement

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Central random

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No data has been generated yet

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The CRF form is collected and managed by the researchers, the electronic CRF form is undertaken by Chengdu Brightech Medical Co., Ltd, and the clinical data is statistically analyzed using SAS or SPSS statistical analysis system.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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