Preventive Intervention Against Lymphedema After Breast Cancer Surgery (LYCA)

Danish Cancer Society

Status: Completed

Conditions: Breast Neoplasms

Treatments: Other: exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02518477

R96-A6604-14-S22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

exercise group

Experimental group

Description:

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.

Treatment:

Other: exercise

usual care control group

No Intervention group

Description:

Receives all standard care offered from the operating hospital and rehabilitation in the municipality.