NCT04272372

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3.6 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

February 12, 2020

Last Update Submit

September 6, 2023

Conditions

Breast Cancer Lymphedema

Keywords

lymphedemabreast cancertreatment

Outcome Measures

Primary Outcomes (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.

    6,12,18, 24 months

Secondary Outcomes (1)

  • Quality of Life status: Lymphedema Quality of Life Questionnaire-Arm (LYMQOL-ARM)

    6,12,18, 24 months

Study Arms (3)

Group 1

Complete Decongestive Therapy

Group 2

Complete Decongestive Therapy + PO Ketoprofen + Local ketoprofen gel

Drug: Ketoprofen

Group 3

Complete Decongestive Therapy + Local Ketoprofen gel

Drug: Ketoprofen

Interventions

KetoprofenDRUG

PO and local therapy

Also known as: Ketoprofen topical
Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lyymphedema patients with breast cancer

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 31815082RESULT

  • 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.

    PMID: 30333315RESULT

  • 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.

    PMID: 20027220RESULT

MeSH Terms

Conditions

Breast Cancer LymphedemaLymphedemaBreast Neoplasms

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Atilla Soran

    University of Pittsburgh Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Prof

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

October 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2025

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share