Breast Cancer, Secondary Lymphedema
Conditions
Keywords
Lymphovenous bypass, Lymphovenous anastomosis, Supermicrosurgery, Lymphangiography, MD Anderson Lymphedema Stage
Brief summary
A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.
Detailed description
This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).
Interventions
PROCEDURESurgery
Lymphovenous anastomosis
OTHERCompression and drainage therapy
Treatment with compression stockings and manual drainage (massage therapy)
Sponsors
University of Oslo
Ohio State University
Sykehuset Telemark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.
Exclusion criteria
* Frequent or severe cellulitis. All other lymphedema.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume | 12 months | Volume of arm as described by submersion and circumference measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life ULL27 | 12 months | To be measured by questionnaire Upper Limb Lymphedema score 27 (ULL27) by Professor Robert Launois at REES France. The scale measures health related quality of life in patients with upper limb lymphedema. Construction: 27 questions rated from 1 (lowest quality of life) to 5 highest quality of life. Dimensions: There are 3 dimensions assessing symptoms, self value, everyday social life. Total score 27-135 Symptom score: 18-90 Self value: 5-25 Social life: 4-20 Question 20 and 22 are part of the self value dimension and are control questions with reverse scores, i.e 1 represents highest quality of life and 5 represents lowest quality of life. The scores for question 20 and 22 are later reversed when adding the total score. |
Countries
Norway
Contacts
Primary ContactLars Johan Sandberg, MD
Outcome results
None listed