Preventive Intervention Against Lymphedema After Breast Cancer Surgery (LYCA)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Other: exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Danish Cancer Society Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Lymphedema measured by water displacement measurement	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
shoulder/arm/leg strength	change from baseline in Newtons in hand held dynometry and in 7RM tests for dynamic muscle strength.	12 months
patient reported pain	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)	12 months
neuropathic pain	Measured by questionnaire assessment on neuropathic pain scale (NeuPPS).	12 months
Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire.	change from baseline in score on the FACIT-fatigue questionnaire	12 months
health related quality of life questionnaire	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).	12 months
International Physical Activity Questionnaire (IPAQ)	Change in physical activity from baseline on the IPAQ	baseline and 12 months
tissue composition by Dual Energy X-ray Apsorptiometry (DXA)	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).	12 months

Collaborators and Investigators

• Sponsor: Danish Cancer Society
• Collaborators: Rigshospitalet, Denmark; Herlev Hospital; Ringsted sygehus
• Investigators: Principal Investigator: Susanne Oksbjerg Dalton, MD PhD, Danish Cancer Society Research Center

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer related lymphedema; resistance training; axillary lymph node dissection; breast cancer surgery
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: R96-A6604-14-S22