Clinical trial NCT02015897: Effect of Physical Therapy on Breast Cancer Related Lymphedema
Official title: Effect of Physical Therapy on Breast Cancer Related Lymphedema; A Multicenter, Randomized, Single-blind, Equivalence Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoedema
Breast Cancer
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. Studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent.

A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive TherapyB (except manual lymphatic drainage

Eligibility criteria: Inclusion Criteria:

* 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
* Completed radiotherapy and/or chemotherapy at least 2 months prior inclusion

Exclusion Criteria:

* 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

Primary outcomes:
measure: The percentage volume reduction of lymphoedema (%)
timeFrame: 7 months
Secondary outcomes:
measure: Differences in circumference of the arm (composite outcome measure), bodyweight, patient sensation of heaviness, patient sensation of tension, and quality of life
timeFrame: 7 months
Other outcomes:
measure: Percentage volume reduction of lymphedema (%) from baseline to week 4. Percentage volume reduction of lymphedema (%) from week 4 to week 7
timeFrame: 7 months
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of Southwest Denmark
state: Region Of Southern Denmark
city: Odense
country: Denmark
facility: Department of Rehabilitation, Odense University Hospital
state: Region Of Southern Denmark
city: Vejle
country: Denmark
facility: Department of Physical Therapy, Lillebaelt Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: THe Hospital of Southwest Denmark
name: Bibi Gram, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.