Lymphedema Treatment Registry

NCT ID: NCT04272372

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-12-31

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

Conditions

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Breast Cancer Lymphedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Complete Decongestive Therapy

No interventions assigned to this group

Group 2

Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel

Ketoprofen

Intervention Type DRUG

PO and local therapy

Group 3

Complete Decongestive Therapy + Local Ketoprofen gel

Ketoprofen

Intervention Type DRUG

PO and local therapy

Interventions

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Ketoprofen

PO and local therapy

Intervention Type DRUG

Other Intervention Names

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Ketoprofen topical

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turkish Lymphedema Society

UNKNOWN

Sponsor Role collaborator

The Breast Health Society, Turkey

OTHER

Sponsor Role collaborator

Ege University

OTHER

Sponsor Role lead

Responsible Party

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Sibel Eyigor

MD, Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atilla Soran

Role: STUDY_CHAIR

University of Pittsburgh Medical Center

References

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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.

Reference Type RESULT
PMID: 31815082 (View on PubMed)

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.

Reference Type RESULT
PMID: 30333315 (View on PubMed)

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.

Reference Type RESULT
PMID: 20027220 (View on PubMed)

Other Identifiers

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LET

Identifier Type: -

Identifier Source: org_study_id

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