Condition category
Cancer
Date applied
28/08/2013
Date assigned
25/10/2013
Last edited
08/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study to find out the effect of "Wei Tan Wai Fu Fang" on the symptoms of postoperative gastroparesis (abnormal functioning of the stomach after surgery) in digestive cancer. We want to see whether it is effective to paste "Wei Tan Wai Fu Fang" on acupuncture point when treating postoperative gastroparesis of digestive cancer.

Who can participate?
The study aims to recruit adult men and women suffering from postoperative gastroparesis of digestive cancer whose local identification of abdomen is cold pattern ,which means this kind of patient prefers heat to cold ,likes hot food and hates cold ones.

What does the study involve?
Over a period of one and a half years participants will be invited to have Wei Tan Wai Fu Fang or placebo (dummy) on two acupuncture points every morning . This can be had along with the routine treatment . At the end of the study , we will find out the effects of having Wei Tan Wai Fu Fang on acupuncture points when treating postoperative gastroparesis of digestive cancer.

What are the possible benefits and risks of participating?
The results of the study are likely to find out a new way to treat the symptoms of postoperative gastroparesis of digestive cancer. The main risk of this study is unknown allergy because Wei Tan Wai Fu Fang includes many Chinese medicinal herbs which are potential allergens. If this occurs, the volunteer can quit the study .

Where is the study run from?
The study is run from the following hospitals in China:
1. Dongfang Hospital affiliated to Beijing University of Chinese Medicine
2. Chinese PLA General Hospital
3. Peking University People's Hospital
4. Cancer Institute and Hospital Chinese Academy of Medical Sciences (CAMS)

When is study starting and how long is it expected to run for?
The recruitment started in mid-2013. Participants will be enrolled in the study for a year and a half.

Who is funding the study?
Beijing Municipal Science and Technology Commission, China.

Who is the main contact?
Dr Kaiwen Hu
wulq1211@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hu Kaiwen

ORCID ID

Contact details

No. 6
District 1
Fangxingyuan
Fangzhuang
Fengtai District
Beijing
P.R. China
Beijing
100078
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D131100002213003

Study information

Scientific title

The clinical study of pasting "Wei Tan Wai Fu Fang" on acupuncture point to treat patients suffering postoperative gastroparesis of digestive cancer: a double-blind randomised parallel group multi-site trial

Acronym

WTWFF

Study hypothesis

It might be effective to paste "Wei Tan Wai Fu Fang" on acupuncture point when treating postoperative gastroparesis of digestive cancer.

Ethics approval

Clinical Research Ethics Committee Office of Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Study design

Double-blind randomised parallel-group multi-site trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Postoperative gastroparesis of digestive cancer

Intervention

This is a double-blind randomised parallel group multi-site trial.120 volunteers are divided into two groups by a certain people who won’t participate in the clinical observation so as to ensure the double-blind observation.
Patients in Group 1 will be treated with “Wei Tan Wai Fu Fang” as well as conventional therapy (parenteral nutrition, gastrointestinal decompression, prokinetic drugs).
Patients in Group 2. will be treated with the placebo of “Wei Tan Wai Fu Fang” and conventional therapy.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical efficiency: It is effective when a patient restores motility in two weeks or he is able to take in nutrients by himself after unplugging the nasogastric tube. It is measured by the Gastroparesis Cardinal Symptom Index.

Secondary outcome measures

1. Gastroparesis symptom score
2. The amount of stomach drainage or vomiting
Outcomes will be recorded on the 1st, 3rd, 5th, 7th and 14th day of the treatment.

Overall trial start date

01/07/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Patients suffering postoperative gastroparesis of digestive cancer
3. Local identification is cold pattern. This means that, this kind of patients prefer warm to cold, likes hot food and hates cold one)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Gastroscope or gastrointestinal contrast detection indicates that the patient is suffering mechanical intestinal obstruction
2. Patients with other diseases such as diabetes or scleroderma ,which may cause gastroparesis
3. Patients taking drugs like morphine and atropine which affect the function of gastic smooth muscle
4. Patients having rash, papules, erythema, herpes, exfoliative dermatitis or ulcerative dermatitis in the abdominal skin

Recruitment start date

01/07/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

China

Trial participating centre

Dongfang Hospital
No. 6, District 1 Fangxingyuan Fangzhuang Fengtai District
Beijing
100078
China

Trial participating centre

Chinese PLA General Hospital
28 Fuxing Road
Beijing
100853
China

Trial participating centre

Peking University People's Hospital
11 Xizhimen S St Xicheng
Beijing
China

Trial participating centre

Cancer Institute and Hospital Chinese Academy of Medical Sciences (CAMS)
No.17 Panjiayuannanli Chaoyang District P.O. Box 2258
Beijing
100021
China

Sponsor information

Organisation

Beijing University of Chinese Medicine (China)

Sponsor details

c/o Kaiwen Hu
11 N. 3rd Ring Rd E
Chaoyang
Beijing
100078
China

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes