Lymphedema Treatment Registry

Study Overview
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Brief Summary
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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
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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

Official Title
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Multi Center Lymphedema Treatment Registry (LET) Study

Conditions
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Breast Cancer Lymphedema

Intervention / Treatment
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* Drug: Ketoprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Complete Decongestive Therapy | |
| Group 2<br>Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel | Drug: Ketoprofen<br>* PO and local therapy<br>* Other names: Ketoprofen topical;|
| Group 3<br>Complete Decongestive Therapy + Local Ketoprofen gel | Drug: Ketoprofen<br>* PO and local therapy<br>* Other names: Ketoprofen topical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb Volume | 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. | 6,12,18, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life status: Lymphedema Quality of Life Questionnaire-Arm (LYMQOL-ARM) | LYMQOL-ARM questionnaire: The LYMQOL-Arm has been developed to assess the impact of lymphedema of the arms on the QoL of the patients. It consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QoL. Domain totals were calculated by adding the individual scores and dividing the total by the number of questions answered (If >50% of questions per domain were not answered this cannot be calculated *and =0). If the item was not scored and left blank or not applicable, this was scored with a 0. The four domains and their corresponding questions are: Function 1 (a-h), 2,3, Appearance 4,5,6,7,8 Symptoms 9,10,11,12,13,14 and Emotion 15,16,17,18,19,20. Overall QoL (Q21) is scored as the value marked by the patient, between 0-10. | 6,12,18, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, breast cancer, treatment