Condition category
Cancer
Date applied
09/09/2013
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 Wen Tong Xiao Zhong Wai Fu Fang in relieving the symptoms of upper limb lymphedema (fluid accumulation) after a radical operation for mastocarcinoma (breast cancer). We want to see whether it is effective to moisten and lay Wen Tong Xiao Zhong Wai Fu Fang on the swollen upper limb.

Who can participate?
The study aims to recruit adult men and women who have had a radical operation for mastocarcinoma, whose swollen limb is colder than the normal one.

What does the study involve?
Participants will be invited to have Wen Tong Xiao Zhong Wai Fu Fang or placebo (dummy) pasted on the swollen upper limb from 9am to 5pm everyday for 14 consecutive days. All participants will receive functional exercises during the treatment. Researchers will measure the upper arm circumference to see how well it has worked. At the end of the study ,this will be compared amongst different patients to find out the effect of Wen Tong Xiao Zhong Wai Fu Fang.

What are the possible benefits and risks of participating?
The results of the study may provide a new way to relieve the symptoms of lymphedema after a radical operation for mastocarcinoma. The main risk of this study is unknown allergy because Wen Tong Xiao Zhong 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 study started in mid-2013. Participants will be enrolled on the study for a period of one and a half years.

Who is funding the study?
Funding has been provided by 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 Kaiwen Hu

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D131100002213003

Study information

Scientific title

Therapeutic effect of upper limb lymphedema after radical operation of mastocarcinoma with Wen Tong Xiao Zhong Wai Fu Fangh for external wet cover: a double-blind randomised parallel group multi-site trial

Acronym

WTXZWFF

Study hypothesis

Wen Tong Xiao Zhong Wai Fu Fang”is a kind of traditional Chinese medicine for external use. It might be effective to moisten and lay "Wen Tong Xiao Zhong Wai Fu Fang" on upper limb lymphedema after radical operation of mastocarcinoma

Ethics approval

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

Study design

Double-blinded 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

Upper limb lymphedema after radical operation of mastocarcinoma

Intervention

The study will involve 96 volunteers recruited at four trial centres. Participation will be for a period of one year and six months. 96 volunteers are divided averagely into two groups.
Patients in Group 1. will be treated with gWen Tong Xiao Zhong Wai Fu Fangh as well as functional exercise.
Patients in Group 2. will be treated with the placebo of gWen Tong Xiao Zhong Wai Fu Fangh and functional exercise.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical efficiency: It is effective when the average upperarm circumference of the swollen limb decrease by 2cm or more.

Secondary outcome measures

Disability of Arm- Shoulder- Hand (DASH)

Overall trial start date

01/07/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Patients suffering radical operation of mastocarcinoma
3. Patients in Stage 1 and 2 based on the 4 stages of upper limb lymphedema after radical operation of mastocarcinoma sorted by American Physical Therapy Association
4. Local identification of cold pattern, which means the swollen limb feels colder than the normal one and this kind of patients prefers warm than cold, likes hot food and hates cold ones

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Patients with other diseases, such as phlebitis, lymphangitis or thrombotic diseases, which may cause upper limb edema
2. Patients suffering lymphatic metastasis
3. Pregnant women and nursing mothers
4. Patients having rash, papules, erythema, herpes, exfoliative dermatitis or ulcerative dermatitis in the affected limb's skin
5. Patients received radiation therapy

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
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 Municipal Science and Technology Commission (China)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Beijing Qihuang Drug Clinical Research Center (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