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
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 wont 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list