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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
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Herlev Hospital
Ringsted sygehus
Information provided by (Responsible Party):
Oksbjerg Dalton, Danish Cancer Society

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Other: exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other: exercise
progressive resistance training

No Intervention: usual care control group
Receives all standard care offered from the operating hospital and rehabilitation in the municipality.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. neuropathic pain [ Time Frame: 12 months ]
    Measured by questionnaire assessment on neuropathic pain scale (NeuPPS).

  4. 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

  5. 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).

  6. International Physical Activity Questionnaire (IPAQ) [ Time Frame: baseline and 12 months ]
    Change in physical activity from baseline on the IPAQ

  7. 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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Denmark
Danish Cancer Society Research Center
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Danish Cancer Society
Rigshospitalet, Denmark
Herlev Hospital
Ringsted sygehus
Investigators
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Principal Investigator: Susanne Oksbjerg Dalton, MD PhD Danish Cancer Society Research Center
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Responsible Party: Oksbjerg Dalton, MD PhD, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT02518477    
Other Study ID Numbers: R96-A6604-14-S22
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Keywords provided by Oksbjerg Dalton, Danish Cancer Society:
breast cancer surgery
axillary lymph node dissection
resistance training
breast cancer related lymphedema
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases