NCT02015897

Brief Summary

The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

3.7 years

First QC Date

December 3, 2013

Last Update Submit

January 30, 2023

Conditions

LymphoedemaBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • The percentage volume reduction of lymphoedema (%)

    7 months

Secondary Outcomes (1)

  • Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life

    7 months

Other Outcomes (1)

  • Percentage volume reduction of lymphedema (%) from baseline to week 4. Percentage volume reduction of lymphedema (%) from week 4 to week 7

    7 months

Study Arms (2)

Physical TherapyB

ACTIVE COMPARATOR

Group B

Procedure: Physical TherapyA

Physical TherapyA

PLACEBO COMPARATOR

Group A

Procedure: Physical TherapyB

Interventions

Physical TherapyAPROCEDURE

Group A: * Skin care * Manual lymphatic drainage * Bandaging using Coban™2Lite * Guidance on physical activity

Physical TherapyB
Physical TherapyBPROCEDURE

Group B: * Skin care * Bandaging using Coban™2Lite * Guidance on physical activity

Physical TherapyA

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnose breast cancer regardless of date for operation and identified lymphoedema
  • Precede ultrasonic scanning of axilla in order to exclude local relapse
  • Lymphoedema \> 2 cm i.e. stage II-III

You may not qualify if:

  • Relapse of breast cancer
  • Untreated infection
  • Untreated heart failure
  • Untreated renal failure
  • Untreated deep venous thrombosis in the arm
  • Unable to participate in physiotherapy treatment and/or not able to understand instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, 6700, Denmark

Location

Department of Rehabilitation, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Department of Physical Therapy, Lillebaelt Hospital

Vejle, Region Syddanmark, 7000, Denmark

Location

Related Publications (2)

  • Tambour M, Holt M, Speyer A, Christensen R, Gram B. Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial. Br J Cancer. 2018 Nov;119(10):1215-1222. doi: 10.1038/s41416-018-0306-4. Epub 2018 Oct 24.

    PMID: 30353049DERIVED

  • Tambour M, Tange B, Christensen R, Gram B. Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial. BMC Cancer. 2014 Apr 3;14:239. doi: 10.1186/1471-2407-14-239.

    PMID: 24708851DERIVED

Related Links

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bibi Gram, PhD

    THe Hospital of Southwest Denmark

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 19, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)