EdemaNCT02627976
Breast Edema Compression Vest
A study testing Compression vest, Thuasne in people with Edema and Lymphedema, run by UMC Utrecht.
Trial summary
A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Edema, Lymphedema, Breast Neoplasm
- What is being tested?
- Compression vest, Thuasne
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jan 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, aged 18 years and older.
- Patient treated with surgery and/or radiotherapy for breast cancer, with symptomatic breast edema (e.g. pain).
- Visual Analog Scale (VAS) pain score of 3 or more.
Who cannot join
- Inability to understand the Dutch language.
- Indicated to undergo radiation treatment of the breast/chestwall within the next 6 months.
- Cardiac complaints.
- Pacemaker.
- Port-a-cath.
- Thrombosis of the arm.
Show all 11Show fewer
- Pulmonary embolism.
- Pulmonary disease.
- Pregnancy.
- Non-breast cancer related lymph edema.
- Clinical depression or anxiety disorder.
About this study
Official title: The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.
A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies.
The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.
Read the detailed description
In this pilot study, a maximum of 40 patients with symptomatic breast edema after surgery and/or radiotherapy for breast cancer are offered treatment with a compression vest. These patients will be followed for 6 months. Recruitment will continue until 20 active vest users are participating.
Primary endpoint is the course of patient reported pain over a 6 month period. Secondary endpoints are the course of degree of breast edema and quality of life over a 6 month period.
Patients who are wearing the vest may experience relief of breast edema related symptoms. In terms of burden, they might experience a tight feeling on the skin while wearing the vest, which could also be the case when treated with compression therapy and taping by a physical therapist. This tight feeling can be overcome by changing the vest to a larger size. All patients will fill out questionnaires upon inclusion, at 2 weeks, and 1, 3 and 6 months. This will take approximately 10-15 minutes per follow-up moment. Patients will have to visit the hospital at baseline and 1, 3 and 6 months after they started wearing the vest (i.e. 25 minute consult with physical examination, photo documentation of the breast and short basic follow-up questions), and it is expected that additional measurements for fitting a new compression vest will need to be taken 2-5 times during participation in the study. Those fitting measurements will be performed at a location as desired by the patient (e.g. UMC Utrecht or at patients' home).
- Conditions
- Edema, Lymphedema, Breast Neoplasm, Breast Cancer
- Being tested
- Compression vest, Thuasne
- Medical subject headings
- Edema, Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression vest, ThuasneDevice
Wearing a compression 4 days/weel with a minumum of 6 hours per day
| Study group | Role | What they receive |
|---|---|---|
| breast edema vest | Active comparator | Not described Receives: Device: Compression vest, Thuasne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of wearing a compression vest on patient reported outcome pain
Brief Pain Inventory (BPI) for pain questionnaire
Measured: At baseline
Effect of wearing a compression vest on patient reported outcome pain two weeks after wearing a compression vest
Brief Pain Inventory (BPI) for pain questionnaire
Measured: 2 weeks
Effect of wearing a compression vest on patient reported outcome pain one month after wearing a compression vest
Brief Pain Inventory (BPI) for pain questionnaire
Measured: 1 month
Effect of wearing a compression vest on patient reported outcome pain three months after wearing a compression vest
Brief Pain Inventory (BPI) for pain questionnaire
Measured: 3 months
Effect of wearing a compression vest on patient reported outcome pain six months after wearing a compression vest
Brief Pain Inventory (BPI) for pain questionnaire
Measured: 6 months
Secondary outcomes (14)
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Measured: At baseline
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Measured: At 1 month
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Measured: At 3 months
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered.
Measured: At 6 months
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-C30 for quality of life and breast edema symptoms
Measured: At baseline
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-C30 for quality of life and breast edema symptoms
Measured: At 2 weeks after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-C30 for quality of life and breast edema symptoms
Measured: At 1 month after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-C30 for quality of life and breast edema symptoms
Measured: At 3 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-C30 for quality of life and breast edema symptoms
Measured: At 6 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Measured: At baseline
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Measured: At 2 weeks after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Measured: At 1 month after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Measured: At 3 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
EORTC QLQ-BR23 for quality of life and breast edema symptoms
Measured: At 6 months after wearing a compression vest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Thuasne
- Responsible party
- Principal investigator, M.L. Gregorowitsch, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627976
- Sponsor's protocol ID
- NL53275.041.15
- Status last verified
- Jan 2018
- First submitted
- 4 Dec 2015
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.
- ClinicalTrials.gov ID
- NCT02627976
- Acronym / sponsor ID
- NL53275.041.15
- Conditions
- Edema, Lymphedema, Breast Neoplasm, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Thuasne
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Dec 2015 (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.
A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies.
The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.
Detailed description
In this pilot study, a maximum of 40 patients with symptomatic breast edema after surgery and/or radiotherapy for breast cancer are offered treatment with a compression vest. These patients will be followed for 6 months. Recruitment will continue until 20 active vest users are participating.
Primary endpoint is the course of patient reported pain over a 6 month period. Secondary endpoints are the course of degree of breast edema and quality of life over a 6 month period.
Patients who are wearing the vest may experience relief of breast edema related symptoms. In terms of burden, they might experience a tight feeling on the skin while wearing the vest, which could also be the case when treated with compression therapy and taping by a physical therapist. This tight feeling can be overcome by changing the vest to a larger size. All patients will fill out questionnaires upon inclusion, at 2 weeks, and 1, 3 and 6 months. This will take approximately 10-15 minutes per follow-up moment. Patients will have to visit the hospital at baseline and 1, 3 and 6 months after they started wearing the vest (i.e. 25 minute consult with physical examination, photo documentation of the breast and short basic follow-up questions), and it is expected that additional measurements for fitting a new compression vest will need to be taken 2-5 times during participation in the study. Those fitting measurements will be performed at a location as desired by the patient (e.g. UMC Utrecht or at patients' home).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast edema vest | Active comparator | Device: Compression vest, Thuasne |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females, aged 18 years and older.
- Patient treated with surgery and/or radiotherapy for breast cancer, with symptomatic breast edema (e.g. pain).
- Visual Analog Scale (VAS) pain score of 3 or more.
Key exclusion criteria (11 listed)
- Inability to understand the Dutch language.
- Indicated to undergo radiation treatment of the breast/chestwall within the next 6 months.
- Cardiac complaints.
- Pacemaker.
- Port-a-cath.
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 |
|---|---|---|
| Compression vest, ThuasneWearing a compression 4 days/weel with a minumum of 6 hours per day | Device | breast edema vest |
Primary outcome
Effect of wearing a compression vest on patient reported outcome pain
Time frame: At baseline
Brief Pain Inventory (BPI) for pain questionnaire
Effect of wearing a compression vest on patient reported outcome pain two weeks after wearing a compression vest
Time frame: 2 weeks
Brief Pain Inventory (BPI) for pain questionnaire
Effect of wearing a compression vest on patient reported outcome pain one month after wearing a compression vest
Time frame: 1 month
Brief Pain Inventory (BPI) for pain questionnaire
Effect of wearing a compression vest on patient reported outcome pain three months after wearing a compression vest
Time frame: 3 months
Brief Pain Inventory (BPI) for pain questionnaire
Effect of wearing a compression vest on patient reported outcome pain six months after wearing a compression vest
Time frame: 6 months
Brief Pain Inventory (BPI) for pain questionnaire
14 secondary outcomes
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
Time frame: At baseline
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
Time frame: At 1 month
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
Time frame: At 3 months
Effect of wearing a compression vest on degree of breast edema (CTCAE score)
Time frame: At 6 months
Effect of wearing a compression vest on patient reported quality of life
Time frame: At baseline
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 2 weeks after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 1 month after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 3 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 6 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
Time frame: At baseline
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 2 weeks after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 1 month after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 3 months after wearing a compression vest
Effect of wearing a compression vest on patient reported quality of life
Time frame: At 6 months after wearing a compression vest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Compression vest, Thuasne in people with Edema and Lymphedema, run by UMC Utrecht.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of wearing a compression vest on patient reported outcome pain (time frame: At baseline). The study lists 5 primary outcomes in all. 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 30 Jan 2018.