Clinical trial NCT04272372: Lymphedema Treatment Registry
Official title: Multi Center Lymphedema Treatment Registry (LET) Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Lymphedema
Keywords: lymphedema
breast cancer
treatment
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Turkish Lymphedema Society
name: The Breast Health Society, Turkey
First posted: 2020-02-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lyymphedema patients with breast cancer

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

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
* Smoking
* Active cancer
* Bleeding history

Primary outcomes:
measure: Limb Volume
timeFrame: 6,12,18, 24 months
Secondary outcomes:
measure: Quality of Life status: Lymphedema Quality of Life Questionnaire-Arm (LYMQOL-ARM)
timeFrame: 6,12,18, 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Atilla Soran
role: STUDY_CHAIR
References:
citation: Forte AJ, Boczar D, Huayllani MT, Lu X, McLaughlin SA. Pharmacotherapy Agents in Lymphedema Treatment: A Systematic Review. Cureus. 2019 Dec 5;11(12):e6300. doi: 10.7759/cureus.6300.
citation: Rockson SG, Tian W, Jiang X, Kuznetsova T, Haddad F, Zampell J, Mehrara B, Sampson JP, Roche L, Kim J, Nicolls MR. Pilot studies demonstrate the potential benefits of antiinflammatory therapy in human lymphedema. JCI Insight. 2018 Oct 18;3(20):e123775. doi: 10.1172/jci.insight.123775.
citation: Nakamura K, Radhakrishnan K, Wong YM, Rockson SG. Anti-inflammatory pharmacotherapy with ketoprofen ameliorates experimental lymphatic vascular insufficiency in mice. PLoS One. 2009 Dec 21;4(12):e8380. doi: 10.1371/journal.pone.0008380.