Lymphedema Treatment Registry

September 6, 2023 updated by: Sibel Eyigor, Ege University

Multi Center Lymphedema Treatment Registry (LET) Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Lyymphedema patients with breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Complete Decongestive Therapy
Group 2
Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel
Drug: Ketoprofen
PO and local therapy
Other Names:
  • Ketoprofen topical
Group 3
Complete Decongestive Therapy + Local Ketoprofen gel
Drug: Ketoprofen
PO and local therapy
Other Names:
  • Ketoprofen topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: 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.
6,12,18, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Collaborators

Turkish Lymphedema Society
The Breast Health Society, Turkey

Investigators

  • Study Chair: Atilla Soran, University of Pittsburgh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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