Breast NeoplasmsLYCANCT02518477
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
A study testing exercise in people with Breast Neoplasms, run by Danish Cancer Society at 1 site in Denmark.
Trial summary
This study will examine whether lymphedema after breast cancer surgery can be reduced. In a randomised controlled design the aim is to investigate whether an early intervention with progressive resistance training and close monitoring of arm swelling can reduce the incidence of lymphedema after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to 31 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- invasive unilateral breast cancer
- undergone Axillary Lymph Node Dissection (ALND), planned for Radiotherapy
- Danish speaking
- consent to participate and to be randomized to either study arm.
Who cannot join
- have undergone primary breast reconstruction
- distant metastases
- physically unable to participate for any reason
- mental illness or cognitive impairment (dementia etc.)
- no past history of lymphedema diagnosis or treatment
- not previously operated with axillary lymph node dissection either side
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LYCA: Preventive Intervention Against Lymphedema After Breast Cancer Surgery - a Randomized Controlled Trial
This study will examine whether lymphedema after breast cancer surgery can be reduced. In a randomised controlled design the aim is to investigate whether an early intervention with progressive resistance training and close monitoring of arm swelling can reduce the incidence of lymphedema after breast cancer surgery.
Read the detailed description
Lymphedema is a well known and much dreaded complication after breast cancer surgery. The aim in this study is to examine if lymphedema can be prevented with early progressive strength training focusing on the arm, and close monitoring of pre clinical lymphedema in the 1 year exercise period. The primary outcome is lymphedema, and secondary outcomes are pain, self-reported symptoms of swelling, sensory disturbance, physical and psychological functioning, fatigue, depression, anxiety and health related quality of life.
158 patients operated for breast cancer with axillary node dissection, will be invited from three hospitals in Denmark, Sealand (Rigshospitalet, Ringsted Hospital, and Herlev Hospital), while on the surgical wards. Two weeks later upon consent they are recruited, baseline tested and randomized to either exercise intervention or usual care control.
The exercise intervention consists of progressive resistance training, combined with a stretching programme, with a total duration of 60 minutes per session. The group attend supervised exercises twice a week and a once weekly home exercise programme of 45 to 60 minutes duration. After 20 weeks, exercises are converted to home exercises, and they are monitored by a weekly sms-service. At 12 months, follow-up measurements are taken for both groups. Lymphedema is defined as 3% limb volume change from the baseline measurement.
- Conditions
- Breast Neoplasms
- Being tested
- exercise
- Keywords
- breast cancer surgery, axillary lymph node dissection, resistance training, breast cancer related lymphedema
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
progressive resistance training
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | The first 20 weeks, twice-weekly 60 minute session of physical exercise supervised by the research assistant and once weekly home exercise programme is offered. The exercise intervention will consist of stretching, scar tissue mobilization and resistance exercises.
For the following 32 weeks a home-training manual specifying three times weekly training is provided. At week 26 an individual booster session will be offered. In the case of lymphedema, referral to trained lymphedema physiotherapist for evaluation of appropriate intervention is made. Receives: Other: exercise |
| usual care control group | No intervention | Receives all standard care offered from the operating hospital and rehabilitation in the municipality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Lymphedema measured by water displacement measurement
Lymphedema is defined as >3% increase in inter limb volume difference compared to baseline, measured by ml. water displaced by lowering arm into a tub of water.
Measured: 12 months
Secondary outcomes (7)
shoulder/arm/leg strength
change from baseline in Newtons in hand held dynometry and in 7RM tests for dynamic muscle strength.
Measured: 12 months
patient reported pain
Pain through the study period measured on a pain scale developed to assess pain after breast cancer surgery by Gärtner et al (JAMA. 2009;302(18):1985-1992)
Measured: 12 months
neuropathic pain
Measured by questionnaire assessment on neuropathic pain scale (NeuPPS).
Measured: 12 months
Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire.
change from baseline in score on the FACIT-fatigue questionnaire
Measured: 12 months
health related quality of life questionnaire
Change from baseline in Health-related quality of life Self-report, The European Organisation for Research and Treatment of Cancer (EORTC QLQ C30), breast cancer specific module (BR 23).
Measured: 12 months
International Physical Activity Questionnaire (IPAQ)
Change in physical activity from baseline on the IPAQ
Measured: baseline and 12 months
tissue composition by Dual Energy X-ray Apsorptiometry (DXA)
Change from baseline in tissue composition of bone mass, lean mass and fat mass, both regional and overall, assessed by Dual Energy X-ray absorptiometry (DXA).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital, Ringsted sygehus
- Responsible party
- Principal investigator, Oksbjerg Dalton, Danish Cancer Society
- Investigators
- Susanne Oksbjerg Dalton, MD PhD, Principal investigator, Danish Cancer Society Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518477
- Sponsor's protocol ID
- R96-A6604-14-S22
- Acronym
- LYCA
- Status last verified
- Sep 2018
- First submitted
- 4 Aug 2015
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LYCA: Preventive Intervention Against Lymphedema After Breast Cancer Surgery - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02518477
- Acronym / sponsor ID
- LYCA / R96-A6604-14-S22
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer surgery, axillary lymph node dissection, resistance training, breast cancer related lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital, Ringsted sygehus
- Study start
- Sep 2015
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 7 Aug 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.
This study will examine whether lymphedema after breast cancer surgery can be reduced. In a randomised controlled design the aim is to investigate whether an early intervention with progressive resistance training and close monitoring of arm swelling can reduce the incidence of lymphedema after breast cancer surgery.
Detailed description
Lymphedema is a well known and much dreaded complication after breast cancer surgery. The aim in this study is to examine if lymphedema can be prevented with early progressive strength training focusing on the arm, and close monitoring of pre clinical lymphedema in the 1 year exercise period. The primary outcome is lymphedema, and secondary outcomes are pain, self-reported symptoms of swelling, sensory disturbance, physical and psychological functioning, fatigue, depression, anxiety and health related quality of life.
158 patients operated for breast cancer with axillary node dissection, will be invited from three hospitals in Denmark, Sealand (Rigshospitalet, Ringsted Hospital, and Herlev Hospital), while on the surgical wards. Two weeks later upon consent they are recruited, baseline tested and randomized to either exercise intervention or usual care control.
The exercise intervention consists of progressive resistance training, combined with a stretching programme, with a total duration of 60 minutes per session. The group attend supervised exercises twice a week and a once weekly home exercise programme of 45 to 60 minutes duration. After 20 weeks, exercises are converted to home exercises, and they are monitored by a weekly sms-service. At 12 months, follow-up measurements are taken for both groups. Lymphedema is defined as 3% limb volume change from the baseline measurement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: exerciseThe first 20 weeks, twice-weekly 60 minute session of physical exercise supervised by the research assistant and once weekly home exercise programme is offered. The exercise intervention will consist of stretching, scar tissue mobilization and resistance exercises. For the following 32 weeks a home-training manual specifying three times weekly training is provided. At week 26 an individual booster session will be offered. In the case of lymphedema, referral to trained lymphedema physiotherapist for evaluation of appropriate intervention is made. |
| usual care control group | No intervention | –Receives all standard care offered from the operating hospital and rehabilitation in the municipality. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- invasive unilateral breast cancer
- undergone Axillary Lymph Node Dissection (ALND), planned for Radiotherapy
- Danish speaking
- consent to participate and to be randomized to either study arm.
Key exclusion criteria (6 listed)
- have undergone primary breast reconstruction
- distant metastases
- physically unable to participate for any reason
- mental illness or cognitive impairment (dementia etc.)
- no past history of lymphedema diagnosis or treatment
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 |
|---|---|---|
| exerciseprogressive resistance training | Other | exercise group |
Primary outcome
Number of participants with Lymphedema measured by water displacement measurement
Time frame: 12 months
Lymphedema is defined as >3% increase in inter limb volume difference compared to baseline, measured by ml. water displaced by lowering arm into a tub of water.
7 secondary outcomes
shoulder/arm/leg strength
Time frame: 12 months
patient reported pain
Time frame: 12 months
neuropathic pain
Time frame: 12 months
Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire.
Time frame: 12 months
health related quality of life questionnaire
Time frame: 12 months
International Physical Activity Questionnaire (IPAQ)
Time frame: baseline and 12 months
tissue composition by Dual Energy X-ray Apsorptiometry (DXA)
Time frame: 12 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 14 Sep 2018.
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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.
Susanne Oksbjerg Dalton, MD PhD principal investigator
Danish Cancer Society Research Center
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 in people with Breast Neoplasms, run by Danish Cancer Society at 1 site 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 14 Sep 2018. 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 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. 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?
Number of participants with Lymphedema measured by water displacement measurement (time frame: 12 months). 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 14 Sep 2018.