Preventive Intervention Against Lymphedema After Breast Cancer Surgery (LYCA)
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|ClinicalTrials.gov Identifier: NCT02518477|
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Other: exercise||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||LYCA: Preventive Intervention Against Lymphedema After Breast Cancer Surgery - a Randomized Controlled Trial|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
Experimental: exercise group
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.
progressive resistance training
No Intervention: usual care control group
Receives all standard care offered from the operating hospital and rehabilitation in the municipality.
- 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.
- shoulder/arm/leg strength [ Time Frame: 12 months ]change from baseline in Newtons in hand held dynometry and in 7RM tests for dynamic muscle strength.
- patient reported pain [ Time Frame: 12 months ]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)
- neuropathic pain [ Time Frame: 12 months ]Measured by questionnaire assessment on neuropathic pain scale (NeuPPS).
- Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire. [ Time Frame: 12 months ]change from baseline in score on the FACIT-fatigue questionnaire
- health related quality of life questionnaire [ Time Frame: 12 months ]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).
- International Physical Activity Questionnaire (IPAQ) [ Time Frame: baseline and 12 months ]Change in physical activity from baseline on the IPAQ
- tissue composition by Dual Energy X-ray Apsorptiometry (DXA) [ Time Frame: 12 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518477
|Danish Cancer Society Research Center|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Susanne Oksbjerg Dalton, MD PhD||Danish Cancer Society Research Center|