Preventive Intervention Against Lymphedema After Breast Cancer Surgery

Breast Neoplasms Clinical Trial

— LYCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518477
• Other study ID #: R96-A6604-14-S22
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2018
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema

Intervention

Other:
• exercise
progressive resistance training

Locations

Country	Name	City	State
Denmark	Danish Cancer Society Research Center	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Danish Cancer Society	Herlev Hospital, Rigshospitalet, Denmark, Ringsted sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	shoulder/arm/leg strength	change from baseline in Newtons in hand held dynometry and in 7RM tests for dynamic muscle strength.	12 months
Secondary	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
Secondary	neuropathic pain	Measured by questionnaire assessment on neuropathic pain scale (NeuPPS).	12 months
Secondary	Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire.	change from baseline in score on the FACIT-fatigue questionnaire	12 months
Secondary	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
Secondary	International Physical Activity Questionnaire (IPAQ)	Change in physical activity from baseline on the IPAQ	baseline and 12 months
Secondary	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