Skip to main content
OpenTrials
Completed

NCT Number: NCT02518477

Preventive Intervention Against Lymphedema After Breast Cancer Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Neoplasms Breast Cancer Lymphedema Breast Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Danish Cancer Society Research Center

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

progressive resistance training

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Collaborators

  • Herlev Hospital
  • Rigshospitalet, Denmark
  • Ringsted sygehus

Registry information

Official study title

LYCA: Preventive Intervention Against Lymphedema After Breast Cancer Surgery - a Randomized Controlled Trial

Acronym: LYCA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2015
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.