Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Breast Cancer Clinical Trial

Official title:

Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578380
• Other study ID #: Prosjektnr 1097.19
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Sykehuset Telemark
• Contact: Lars Johan Sandberg, MD
• Phone: +4735003456
• Email: johansandberg[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Secondary Lymphedema

Intervention

Procedure:
• Surgery
Lymphovenous anastomosis

Other:
• Compression and drainage therapy
Treatment with compression stockings and manual drainage (massage therapy)

Locations

Country	Name	City	State
Norway	Sykehuset Telemark	Skien	Telemark

Sponsors (3)

Lead Sponsor	Collaborator
Sykehuset Telemark	Ohio State University, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume	Volume of arm as described by submersion and circumference measures	12 months
Secondary	Health related quality of life ULL27	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.	12 months