Lymphedema Treatment Registry

Ege University

Status: Not yet enrolling

Conditions: Breast Cancer Lymphedema

Treatments: Drug: Ketoprofen

Study type: Observational

Funder types: Other

Identifiers

NCT04272372

LET

Details and patient eligibility

About

Patients with breast cancer related lymphedema (clinical stage 0-2) will include in this study. Patients will take their demographic and clinical history and will evaluate with measurements of extremity volumes, body mass index, quality of life status and image studies (lymphoscintigraphy, Ultrasonography (USG), Indocyanine Green (ICG) Lymphograph or magnetic resonance imaging (MRI)) before and after the complete decongestive therapy. Outcome measurements such as limb volume, quality of life questionnaire and USG will repeat every 6,12,18, 24 months.

Full description

Patients with breast cancer related lymphedema (clinical stage 0-2) will include in this study. Patients will take their demographic and clinical history and will evaluate with measurements of extremity volumes, body mass index, quality of life status and image studies (lymphoscintigraphy, USG, ICG or MRI) before and after the complete decongestive therapy (CDT). Outcome measurements such as limb volume, quality of life questionnaire and USG will repeat every 6,12,18, 24 months.

Group 1: CDT Group 2: CDT + PO ketoprofen +Local ketoprofen gel Group 3: CDT + Local ketoprofen gel

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer
• Lymphedema more than 6 months
• Lymphedema stage 0-2
• Completed treatment (CT-RT)

Exclusion criteria

• Stage 3 lymphedema
• Cardiovasculary disease
• Hepatic disease
• Kidney disease
• Cerebrovascular event
• Metastasis
• Gastritis
• Infection
• Smoking
• Active cancer
• Bleeding history

Trial design

60 participants in 3 patient groups

Group 1

Description:

Complete Decongestive Therapy

Group 2

Description:

Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel

Treatment:

Drug: Ketoprofen

Group 3

Description:

Complete Decongestive Therapy + Local Ketoprofen gel

Treatment:

Drug: Ketoprofen