LymphoedemaNCT02015897
Effect of Physical Therapy on Breast Cancer Related Lymphedema
A study testing Physical TherapyA and Physical TherapyB in people with Lymphoedema and Breast Cancer, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.
Trial summary
The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Lymphoedema, Breast Cancer
- What is being tested?
- Physical TherapyA and Physical TherapyB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesDenmark
- Study dates
- Jan 2014to 1 Sep 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 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnose breast cancer regardless of date for operation and identified lymphoedema
- Precede ultrasonic scanning of axilla in order to exclude local relapse
- Lymphoedema > 2 cm i.e. stage II-III
- Completed radiotherapy and/or chemotherapy at least 2 months prior inclusion
Who cannot join
- Relapse of breast cancer
- Untreated infection
- Untreated heart failure
- Untreated renal failure
- Untreated deep venous thrombosis in the arm
- Unable to participate in physiotherapy treatment and/or not able to understand instructions
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Hospital of Southwest Denmark
Esbjerg, Region Syddanmark, 6700
Department of Rehabilitation, Odense University Hospital
Odense, Region Syddanmark, 5000
Department of Physical Therapy, Lillebaelt Hospital
Vejle, Region Syddanmark, 7000
About this study
Official title: Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial
The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.
Read the detailed description
Physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. Studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent.
A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive TherapyB (except manual lymphatic drainage
- Conditions
- Lymphoedema, Breast Cancer
- Being tested
- Physical TherapyA, Physical TherapyB
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyAProcedure or surgery
Group A:
- Skin care
- Manual lymphatic drainage
- Bandaging using Coban™2Lite
- Guidance on physical activity
Physical TherapyBProcedure or surgery
Group B:
- Skin care
- Bandaging using Coban™2Lite
- Guidance on physical activity
| Study group | Role | What they receive |
|---|---|---|
| Physical TherapyB | Active comparator | Group B Receives: Procedure: Physical TherapyA |
| Physical TherapyA | Placebo comparator | Group A Receives: Procedure: Physical TherapyB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage volume reduction of lymphoedema (%)
Measured: 7 months
Secondary outcomes (1)
Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life
Circumference of the arm consists of 7 measurements but these will be converted to one outcome measure when estimating the difference between baseline and post intervention measurements
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphoedemaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valgerdur Hilmarsdottir Gram, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Bibi Gram, PhD, Study director, THe Hospital of Southwest Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015897
- Sponsor's protocol ID
- S-20130091
- Status last verified
- Jan 2023
- First submitted
- 3 Dec 2013
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tambour M, Holt M, Speyer A, Christensen R, Gram B. Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial. Br J Cancer. 2018 Nov;119(10):1215-1222. doi: 10.1038/s41416-018-0306-4. Epub 2018 Oct 24.
PubMed 30353049Tambour M, Tange B, Christensen R, Gram B. Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial. BMC Cancer. 2014 Apr 3;14:239. doi: 10.1186/1471-2407-14-239.
PubMed 24708851
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial
- ClinicalTrials.gov ID
- NCT02015897
- Acronym / sponsor ID
- S-20130091
- Conditions
- Lymphoedema, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 19 Dec 2013 (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 objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.
Detailed description
Physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. Studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent.
A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive TherapyB (except manual lymphatic drainage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical TherapyB | Active comparator | Procedure: Physical TherapyAGroup B |
| Physical TherapyA | Placebo comparator | Procedure: Physical TherapyBGroup A |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnose breast cancer regardless of date for operation and identified lymphoedema
- Precede ultrasonic scanning of axilla in order to exclude local relapse
- Lymphoedema > 2 cm i.e. stage II-III
- Completed radiotherapy and/or chemotherapy at least 2 months prior inclusion
Key exclusion criteria (6 listed)
- Relapse of breast cancer
- Untreated infection
- Untreated heart failure
- Untreated renal failure
- Untreated deep venous thrombosis in the arm
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 |
|---|---|---|
| Physical TherapyAGroup A: * Skin care * Manual lymphatic drainage * Bandaging using Coban™2Lite * Guidance on physical activity | Procedure or surgery | Physical TherapyB |
| Physical TherapyBGroup B: * Skin care * Bandaging using Coban™2Lite * Guidance on physical activity | Procedure or surgery | Physical TherapyA |
Primary outcome
The percentage volume reduction of lymphoedema (%)
Time frame: 7 months
1 secondary outcome
Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life
Time frame: 7 months
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 31 Jan 2023.
- Derived from this study: PubMed 30353049Tambour M, Holt M, Speyer A, Christensen R, Gram B. Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial. Br J Cancer. 2018 Nov;119(10):1215-1222. doi: 10.1038/s41416-018-0306-4. Epub 2018 Oct 24.
- Derived from this study: PubMed 24708851Tambour M, Tange B, Christensen R, Gram B. Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial. BMC Cancer. 2014 Apr 3;14:239. doi: 10.1186/1471-2407-14-239.
- Link to the Hospital of Southwest DenmarkLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lymphoedema
RecruitingObservational study
Measuring Fluid Buildup in Cancer Patients
Cancer, Oedema
Not yet recruiting
Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.
Limb Lymphoedema
Recruiting
Effectiveness of Kinesio Taping in Patients With Chronic Breast and/or Truncal Oedema After Treatment for Breast Cancer.
Breast Edema, Breast Cancer Related Lymphoedema
Recruiting
Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial
Lymphedema, Lymphoedema
RecruitingObservational study
Subclinical Monitoring of Lymphatic Function in Oncology Patients for Lymphoedema Prevention (ONCOLYMPH)
Lymphoedema
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.
Bibi Gram, PhD study director
THe Hospital of Southwest Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical TherapyA and Physical TherapyB in people with Lymphoedema and Breast Cancer, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.
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 4 inclusion and 6 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
The percentage volume reduction of lymphoedema (%) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015897, which also lists 2 linked publications.
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 31 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.