NCT02518477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

2.4 years

First QC Date

August 4, 2015

Last Update Submit

September 12, 2018

Conditions

Breast Neoplasms

Keywords

breast cancer surgeryaxillary lymph node dissectionresistance trainingbreast cancer related lymphedema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • shoulder/arm/leg strength

    12 months

  • patient reported pain

    12 months

  • neuropathic pain

    12 months

  • Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire.

    12 months

  • health related quality of life questionnaire

    12 months

  • +2 more secondary outcomes

Study Arms (2)

exercise group

EXPERIMENTAL

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

usual care control group

NO INTERVENTION

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

Interventions

exerciseOTHER

progressive resistance training

exercise group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Cancer Society Research Center

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Cancer Lymphedema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Susanne Oksbjerg Dalton, MD PhD

    Danish Cancer Society Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 7, 2015

Study Start

September 1, 2015

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

DK(1)