Breast NeoplasmDREAMNCT02992782
Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management
A study testing Exercise and Compression Garment and Exercise and Adjustable Compression Wrap in people with Breast Neoplasm and Lymphedema, run by University of Alberta at 1 site in Canada.
Trial summary
Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine the effect of a 12-week decongestive progressive resistance exercise with advanced compression on breast cancer related… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Lymphedema
- What is being tested?
- Exercise and Compression Garment and Exercise and Adjustable Compression Wrap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 28 Aug 2025
- 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
- Is a female with a history of breast cancer;
- Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
- Has unilateral mild to moderate lymphedema of at least 200 ml or 10% inter-limb volume difference or a maximum of 40% and/or minimal volume difference of 100 ml or 5% in hand and forearm region;
- Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
- Is in the lymphedema maintenance phase of conservative treatment;
- Uses a well fitted compression sleeve (not older than 1 month) and is agreeable to wear the sleeve for a minimum of 12 hours per day (providing a minimum of 30 mm Hg of pressure);
- Is agreeable to discontinuing other lymphedema treatments, including manual lymph drainage and intermittent pneumatic compression during the supervised intervention period of the study
Who cannot join
- Are undergoing or are scheduled for chemotherapy, radiotherapy or biological therapy;
- Present with limb infection, deep vein thrombosis, cellulitis, or have active metastatic disease;
- Have any neurological, cognitive deficit or other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
- Have any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
- Have a body mass index (BMI) greater than 40 kg/m2.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4
About this study
Official title: Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial
Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine the effect of a 12-week decongestive progressive resistance exercise with advanced compression on breast cancer related lymphedema. Our objective is to determine if breast cancer survivors are willing and able to wear advanced compression while exercising and if the combination will help to reduce their lymphedema. Twenty-four breast cancer survivors from Edmonton, Alberta will be enrolled in the one-year long study.
Read the detailed description
Lymphedema is a swelling in the arm, chest wall and breast on the side of the breast cancer. Arm lymphedema develops as a result of breast cancer surgery and/ or radiation therapy. Compression therapy and exercise are commonly prescribed treatment to help reduce the arm swelling and to maintain the result. The exercise that is usually prescribed for lymphedema is called decongestive remedial exercise. It involves active, non-resisted movements that follow a specific order from proximal to distal and back proximally. The exercises start at the neck, move to the chest wall and then down the arm, and back.
Two different types of compression garments have been proposed to help reduce swelling when women are exercising. One compression garment is made with a stiffer, less elastic type of material and is called a "flat-knit" garment. The other garment, the "Adjustable Compression Wrap" is a garment with an adjustable elastic strapping system that helps to reinforce the compression on the arm. Recent research suggests that these specialized garments enhance the muscle pump effect on lymph flow; however, no research has been conducted to test whether this actually results in improvements in arm lymphedema volume.
Resistance exercise training helps to improve arm flexibility, strength, function, and quality of life in breast cancer survivors. Recent evidence has shown that breast cancer survivors with lymphedema, can safely perform resistance training (strength training), however, there is no impact (better or worse) on arm lymphedema volume.
To date, no studies have been performed combining all potential therapeutic approaches for lymphedema management: resistance exercise, a therapeutic decongestive exercise sequence, and compression therapy. Women in the experimental arms of this study will wear a compression garment when performing progressive resistance exercise that follows the decongestive sequence. We will examine the effect of the combined intervention on arm lymphedema volume, function and quality of life.
- Conditions
- Breast Neoplasm, Lymphedema
- Being tested
- Standard Care, Exercise and Compression Garment, Exercise and Adjustable Compression Wrap
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Home program of decongestive exercise and daily use of a compression sleeve
Exercise and Compression GarmentBehavioural
Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
Exercise and Adjustable Compression WrapBehavioural
Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Standard care Intervention: including a home program of therapeutic (decongestive) exercise, which will include active, non-resistive motion of the involved limb. Participants will perform the exercise once daily for about 10 minutes and will be required to wear their compression sleeve for at least 12 hours per day, each day of the week. After 24 weeks, they will be given the opportunity to take part in the decongestive progressive resistance exercise program and will be provided with an adjustable compression garment to use during exercise. Receives: Behavioral: Standard Care |
| Exercise and Compression Garment | Experimental | Intervention will include having participants wear a compression sleeve during exercise. They will wear the sleeve while carrying out the decongestive progressive resistance exercise program and will continue wearing their day-time compression garment for at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 Weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness center or at home. Receives: Behavioral: Exercise and Compression Garment |
| Exercise and Adjustable Compression Wrap | Experimental | Intervention will include having participants will be fitted for an adjustable compression wrap. They will be required to wear the adjustable compression wrap during the decongestive progressive resistance exercise program and will continue wearing their compression sleeve at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness centre or at home. Receives: Behavioral: Exercise and Adjustable Compression Wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Lymphedema Volume
Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
Measured: Change from baseline to 12 weeks
Secondary outcomes (10)
Bioimpedance Analysis
Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
Measured: Change from baseline to 12 weeks
Upper body strength
One repetition maximum strength for bench press and seated row
Measured: Change baseline to 12 weeks
Lower body strength
One repetition maximum strength for leg press
Measured: Change baseline to 12 weeks
Shoulder range of motion
Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements
Measured: Change baseline to 12 weeks
Lymphedema International Classification of Functioning (LYMPH-ICF)
Lymphedema-specific quality of life
Measured: Change baseline to 12-weeks
Rand Short-form (SF): 36
General health-related quality of life
Measured: Change baseline to 12-weeks
Godin Leisure-time Questionnaire
Physical activity level in previous 4-week period
Measured: Change baseline to 12-weeks
Body composition
Body mass index as calculated by body weight and height metrics
Measured: Change baseline to 12-weeks
Body Image
Body Image and Relationship in past month
Measured: Change baseline to 12-weeks
Tissue Composition
Magnetic Resonance Imaging: fat, water and muscle mass
Measured: Change baseline to 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start1 Jun 2017
- Primary completion14 Aug 2023
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Margaret L McNeely, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992782
- Sponsor's protocol ID
- HREBA - CC 16-1026
- Acronym
- DREAM
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2016
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02992782
- Acronym / sponsor ID
- DREAM / HREBA - CC 16-1026
- Conditions
- Breast Neoplasm, Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 14 Dec 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.
Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine the effect of a 12-week decongestive progressive resistance exercise with advanced compression on breast cancer related lymphedema. Our objective is to determine if breast cancer survivors are willing and able to wear advanced compression while exercising and if the combination will help to reduce their lymphedema. Twenty-four breast cancer survivors from Edmonton, Alberta will be enrolled in the one-year long study.
Detailed description
Lymphedema is a swelling in the arm, chest wall and breast on the side of the breast cancer. Arm lymphedema develops as a result of breast cancer surgery and/ or radiation therapy. Compression therapy and exercise are commonly prescribed treatment to help reduce the arm swelling and to maintain the result. The exercise that is usually prescribed for lymphedema is called decongestive remedial exercise. It involves active, non-resisted movements that follow a specific order from proximal to distal and back proximally. The exercises start at the neck, move to the chest wall and then down the arm, and back.
Two different types of compression garments have been proposed to help reduce swelling when women are exercising. One compression garment is made with a stiffer, less elastic type of material and is called a "flat-knit" garment. The other garment, the "Adjustable Compression Wrap" is a garment with an adjustable elastic strapping system that helps to reinforce the compression on the arm. Recent research suggests that these specialized garments enhance the muscle pump effect on lymph flow; however, no research has been conducted to test whether this actually results in improvements in arm lymphedema volume.
Resistance exercise training helps to improve arm flexibility, strength, function, and quality of life in breast cancer survivors. Recent evidence has shown that breast cancer survivors with lymphedema, can safely perform resistance training (strength training), however, there is no impact (better or worse) on arm lymphedema volume.
To date, no studies have been performed combining all potential therapeutic approaches for lymphedema management: resistance exercise, a therapeutic decongestive exercise sequence, and compression therapy. Women in the experimental arms of this study will wear a compression garment when performing progressive resistance exercise that follows the decongestive sequence. We will examine the effect of the combined intervention on arm lymphedema volume, function and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareStandard care Intervention: including a home program of therapeutic (decongestive) exercise, which will include active, non-resistive motion of the involved limb. Participants will perform the exercise once daily for about 10 minutes and will be required to wear their compression sleeve for at least 12 hours per day, each day of the week. After 24 weeks, they will be given the opportunity to take part in the decongestive progressive resistance exercise program and will be provided with an adjustable compression garment to use during exercise. |
| Exercise and Compression Garment | Experimental | Behavioral: Exercise and Compression GarmentIntervention will include having participants wear a compression sleeve during exercise. They will wear the sleeve while carrying out the decongestive progressive resistance exercise program and will continue wearing their day-time compression garment for at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 Weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness center or at home. |
| Exercise and Adjustable Compression Wrap | Experimental | Behavioral: Exercise and Adjustable Compression WrapIntervention will include having participants will be fitted for an adjustable compression wrap. They will be required to wear the adjustable compression wrap during the decongestive progressive resistance exercise program and will continue wearing their compression sleeve at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness centre or at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is a female with a history of breast cancer;
- Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
- Has unilateral mild to moderate lymphedema of at least 200 ml or 10% inter-limb volume difference or a maximum of 40% and/or minimal volume difference of 100 ml or 5% in hand and forearm region;
- Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
- Is in the lymphedema maintenance phase of conservative treatment;
Key exclusion criteria (5 listed)
- Are undergoing or are scheduled for chemotherapy, radiotherapy or biological therapy;
- Present with limb infection, deep vein thrombosis, cellulitis, or have active metastatic disease;
- Have any neurological, cognitive deficit or other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
- Have any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
- Have a body mass index (BMI) greater than 40 kg/m2.
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 |
|---|---|---|
| Standard CareHome program of decongestive exercise and daily use of a compression sleeve | Behavioural | Standard Care |
| Exercise and Compression GarmentDecongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve | Behavioural | Exercise and Compression Garment |
| Exercise and Adjustable Compression WrapDecongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve | Behavioural | Exercise and Adjustable Compression Wrap |
Primary outcome
Arm Lymphedema Volume
Time frame: Change from baseline to 12 weeks
Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
10 secondary outcomes
Bioimpedance Analysis
Time frame: Change from baseline to 12 weeks
Upper body strength
Time frame: Change baseline to 12 weeks
Lower body strength
Time frame: Change baseline to 12 weeks
Shoulder range of motion
Time frame: Change baseline to 12 weeks
Lymphedema International Classification of Functioning (LYMPH-ICF)
Time frame: Change baseline to 12-weeks
Rand Short-form (SF): 36
Time frame: Change baseline to 12-weeks
Godin Leisure-time Questionnaire
Time frame: Change baseline to 12-weeks
Body composition
Time frame: Change baseline to 12-weeks
Body Image
Time frame: Change baseline to 12-weeks
Tissue Composition
Time frame: Change baseline to 12-weeks
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 13 Jan 2026.
- Individual participant dataSharing planned: Yes. On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
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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.
Margaret L McNeely, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Compression Garment and Exercise and Adjustable Compression Wrap in people with Breast Neoplasm and Lymphedema, run by University of Alberta at 1 site in Canada.
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 7 inclusion and 5 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 13 Jan 2026. 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 Canada. 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?
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?
Arm Lymphedema Volume (time frame: Change from baseline to 12 weeks). 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 13 Jan 2026.