Therapeutic effect of upper limb lymphedema after radical operation of mastocarcinoma with Wen Tong Xiao Zhong Wai Fu Fangh for external wet cover
| ISRCTN | ISRCTN43361464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43361464 |
| Secondary identifying numbers | D131100002213003 |
- Submission date
- 09/09/2013
- Registration date
- 25/10/2013
- Last edited
- 08/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
No. 6, District 1, Fangxingyuan
Fangzhuang
Fengtai District
Beijing
100078
China
Study information
| Study design | Double-blinded randomised parallel-group multi-site trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Therapeutic effect of upper limb lymphedema after radical operation of mastocarcinoma with Wen Tong Xiao Zhong Wai Fu Fangh for external wet cover: a double-blind randomised parallel group multi-site trial |
| Study acronym | WTXZWFF |
| Study objectives | Wen Tong Xiao Zhong Wai Fu Fangis 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(s) | Clinical Research Ethics Committee Office of Dongfang Hospital Affiliated to Beijing University of Chinese Medicine |
| Health condition(s) or problem(s) studied | 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 Fangh as well as functional exercise. Patients in Group 2. will be treated with the placebo of gWen Tong Xiao Zhong Wai Fu Fangh and functional exercise. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/07/2013 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 96 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- China
Study participating centres
Fangxingyuan
Beijing
100078
China
Beijing
100853
China
Xicheng
Beijing
China
Chaoyang District
P.O. Box 2258
Beijing
100021
China
Sponsor information
Government
c/o Kaiwen Hu
11 N. 3rd Ring Rd E
Chaoyang
Beijing
100078
China
"ROR" |
https://ror.org/034k14f91 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
