Breast Cancer Lymphedema
Conditions
Keywords
lymphedema, breast cancer, treatment
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
Interventions
DRUGKetoprofen
PO and local therapy
Sponsors
Turkish Lymphedema Society
The Breast Health Society, Turkey
Ege University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limb Volume | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life status: Lymphedema Quality of Life Questionnaire-Arm (LYMQOL-ARM) | 6,12,18, 24 months | 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. |
Outcome results
None listed