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Breast Cancer LymphedemaNCT04272372

Lymphedema Treatment Registry

An observational study of Breast Cancer Lymphedema, run by Ege University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Lymphedema
What is being tested?
Ketoprofen
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2023to Dec 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Lyymphedema patients with breast cancer

Who may be able to join

  • Breast cancer
  • Lymphedema more than 6 months
  • Lymphedema stage 0-2
  • Completed treatment (CT-RT)

Who cannot join

  • Stage 3 lymphedema
  • Cardiovasculary disease
  • Hepatic disease
  • Kidney disease
  • Cerebrovascular event
  • Metastasis
Show all 11Show fewer
  • Gastritis
  • Infection
  • Smoking
  • Active cancer
  • Bleeding history

About this study

Official title: 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.

Read the 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

Being tested
Ketoprofen
Keywords
lymphedema, breast cancer, treatment
Medical subject headings
Breast Cancer Lymphedema, Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetoprofenDrug

    Also called Ketoprofen topical

    PO and local therapy

Study groups in NCT04272372
Study groupRoleWhat they receive
Group 1Complete Decongestive Therapy
Group 2Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel
Receives: Drug: Ketoprofen
Group 3Complete Decongestive Therapy + Local Ketoprofen gel
Receives: Drug: Ketoprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6,12,18, 24 months

Secondary outcomes (1)

  1. 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.

    Measured: 6,12,18, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study startOct 2023 (estimated)
  3. Primary completionNov 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272372
Sponsor's protocol ID
LET
Status last verified
Sep 2023
First submitted
12 Feb 2020
Last updated
7 Sep 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31815082

  • 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.

    PubMed 30333315

  • 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.

    PubMed 20027220

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Lymphedema, run by Ege University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Limb Volume (time frame: 6,12,18, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272372, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.

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