Clinical trial NCT02518477: Preventive Intervention Against Lymphedema After Breast Cancer Surgery
Official title: LYCA: Preventive Intervention Against Lymphedema After Breast Cancer Surgery - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: breast cancer surgery
axillary lymph node dissection
resistance training
breast cancer related lymphedema
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Herlev Hospital
name: Ringsted sygehus
First posted: 2015-08-07
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with Lymphedema measured by water displacement measurement
timeFrame: 12 months
Secondary outcomes:
measure: shoulder/arm/leg strength
timeFrame: 12 months
measure: patient reported pain
timeFrame: 12 months
measure: neuropathic pain
timeFrame: 12 months
measure: Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire.
timeFrame: 12 months
measure: health related quality of life questionnaire
timeFrame: 12 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline and 12 months
measure: tissue composition by Dual Energy X-ray Apsorptiometry (DXA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Cancer Society Research Center
Study officials:
affiliation: Danish Cancer Society Research Center
name: Susanne Oksbjerg Dalton, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: