Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Breast Neoplasms

Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Conservative treatment with physiotherapy and compression

Surgery

Treatment with compression stockings and manual drainage (massage therapy)

Compression and drainage therapy

Lars Johan Sandberg, MD

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.

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).

Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

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

There is no plan to share IPD with other researchers

Volume of arm as described by submersion and circumference measures

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.

University of Oslo

Ohio State University

Sykehuset Telemark

Rare Diseases

Carcinoma

Melanoma

Inflammatory Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Inflammatory Breast Cancer

Neuroendocrine Tumor

Neuroepithelioma

Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.

Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.

Indocyanine Green

Lymphangiography

Lymphovenous Bypass

Mark Schaverien

Sara Hull, BSN,MHA,RN

This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.

PRIMARY OBJECTIVES:

I. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.

SECONDARY OBJECTIVES:

I. Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.

GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.

After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.

Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma

Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study

If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.

Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Supermicrosurgery for Breast Cancer Survivors With Lymphedema.	NCT03578380	Secondary Lymph... Breast Cancer	Surgery Compression and...	-	Sykehuset Telemark
Supermicrosurgery for Breast Cancer Survivors With Lymphedema.	NCT03578380	Secondary Lymph... Breast Cancer	Surgery Compression and...	-	Sykehuset Telemark
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma	NCT03941756	Anatomic Stage ... Breast Inflamma... Locally Advance... Melanoma	Indocyanine Gre... Lymphangiograph... Lymphovenous By...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for lymphovenous bypass