Multi Center Lymphedema Treatment Registry (LET) Study
Overview
- Phase
- Not Applicable
- Intervention
- Ketoprofen
- Conditions
- Breast Cancer Lymphedema
- Sponsor
- Ege University
- Enrollment
- 60
- Primary Endpoint
- Limb Volume
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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
Investigators
Sibel Eyigor
MD, Prof
Ege University
Eligibility Criteria
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
- •Active cancer
- •Bleeding history
Arms & Interventions
Group 2
Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel
Intervention: Ketoprofen
Group 3
Complete Decongestive Therapy + Local Ketoprofen gel
Intervention: Ketoprofen
Outcomes
Primary Outcomes
Limb Volume
Time Frame: 6,12,18, 24 months
Volume measurements will take using ulnar styloid process as a index point, and circumferential measurements will take with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm is calculate and record before and after the treatment for both arms. All patients' measurements before and after complete decongestive therapy will take by the same researcher. Volume changes will be evaluated at the 6th, 12th, 18th and 24.th months.
Secondary Outcomes
- Quality of Life status: Lymphedema Quality of Life Questionnaire-Arm (LYMQOL-ARM)(6,12,18, 24 months)