Breast CancerNCT02707835
Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping
A study testing self massage, manual lymph drainage and epidermis fascia taping in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown. The purpose of this study is to investigate 1. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- self massage, manual lymph drainage and epidermis fascia taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age:20~80 y/o
- female patients with unilateral breast cancer after surgery
- unilateral lymph edema ( circumference of affected side 2cm bigger than sound side）
- do not receive any treatment of lymph edema Exclusion criteria
- 1. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 110
Jing-Lan Yang, 886-2-23123456-67564, yangjinglan@gmail.com
About this study
Official title: The Effect of Edema Control in Patients With Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping With Ultrasonography
The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown.
The purpose of this study is to investigate
Read more
- The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.
- The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.
Our hypothesis :
- The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.
- Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.
- Conditions
- Breast Cancer
- Being tested
- self massage, manual lymph drainage, epidermis fascia taping
- Keywords
- Edema,taping,ultrasound
- Medical subject headings
- Breast Neoplasms, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self massageOther
self massage, skin care education, manual lymph drainage exercise, compression garment
manual lymph drainageOther
manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
epidermis fascia tapingOther
epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | self massage, skin care education, manual lymph drainage exercise, compression garment Receives: Other: self massage |
| manual lymph drainage group | Active comparator | manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment Receives: Other: manual lymph drainage |
| experimental group | Experimental | epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment Receives: Other: epidermis fascia taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of epidermis and dermis
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing-Lan Yang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707835
- Sponsor's protocol ID
- 201505100RIND
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Edema Control in Patients With Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping With Ultrasonography
- ClinicalTrials.gov ID
- NCT02707835
- Acronym / sponsor ID
- 201505100RIND
- Conditions
- Breast Cancer
- Keywords
- Edema,taping,ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown.
The purpose of this study is to investigate
- The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.
- The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.
Our hypothesis :
- The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.
- Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: self massageself massage, skin care education, manual lymph drainage exercise, compression garment |
| manual lymph drainage group | Active comparator | Other: manual lymph drainagemanual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment |
| experimental group | Experimental | Other: epidermis fascia tapingepidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age:20~80 y/o
- female patients with unilateral breast cancer after surgery
- unilateral lymph edema ( circumference of affected side 2cm bigger than sound side）
- do not receive any treatment of lymph edema Exclusion criteria
- 1. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self massageself massage, skin care education, manual lymph drainage exercise, compression garment | Other | control group |
| manual lymph drainagemanual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment | Other | manual lymph drainage group |
| epidermis fascia tapingepidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment | Other | experimental group |
Primary outcome
thickness of epidermis and dermis
Time frame: 10 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Lan Yang principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self massage, manual lymph drainage and epidermis fascia taping in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Lan Yang (886-2-23123456-67564, yangjinglan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of epidermis and dermis (time frame: 10 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.