NCT06572098

Brief Summary

It is aimed to determine the changes of complex decongestive therapy applications on oxidative stress parameters and antioxidants in patients with lymphedema after breast cancer treatment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress52%
Apr 2024Apr 2028

Study Start

First participant enrolled

April 3, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2028

Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

August 23, 2024

Last Update Submit

September 20, 2024

Conditions

What Are the Effects of Lymphedema Treatment

Keywords

Breast cancerLymphedemaOxidative stress

Outcome Measures

Primary Outcomes (1)

  • PON1

    Paraoxonase

    will be assessed before treatment, immediately after treatment and one month after treatment.

Secondary Outcomes (1)

  • OSİ

    will be assessed before treatment, immediately after treatment and one month after treatment.

Other Outcomes (5)

  • LDL

    will be assessed before treatment, immediately after treatment and one month after treatment.

  • HDL

    will be assessed before treatment, immediately after treatment and one month after treatment.

  • Trigliserit

    will be assessed before treatment, immediately after treatment and one month after treatment.

  • +2 more other outcomes

Study Arms (2)

working group

ACTIVE COMPARATOR

Patients will receive ten sessions of complex decongestive therapy. Patients will be evaluated for oxidative stress and antioxidant levels in three stages: before treatment, immediately after treatment and one month after the end of treatment.

Other: Complex decongestive therapy

control group

NO INTERVENTION

As an evaluation parameter, a healthy female control group will be formed at least as many as the number of patients with lymphedema included in the study.

Interventions

Complex decongestive therapyOTHER

Complex decongestive therapy consists of 4 phases. It will be performed by a lymphedema physiotherapist trained in Complex Decongestive Physiotherapy. Complex decongestive therapy consists of manual lymph drainage, skin care, multilayer bandaging and therapeutic exercises.

working group

Eligibility Criteria

Age25 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Development of lymphedema after breast cancer treatment
  • Clinical stage of lymphedema Stage-2 or Stage-3 diagnosis

You may not qualify if:

  • Receiving treatment for lymphedema in the last three months
  • Those diagnosed with severe heart failure and/or arrhythmia
  • Persistent infection in the affected extremities
  • Ongoing chemotherapy treatment
  • Diagnosed with liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Adana, çukurova, 01250, Turkey (Türkiye)

Location

Related Publications (2)

  • O'Toole J, Jammallo LS, Skolny MN, Miller CL, Elliott K, Specht MC, Taghian AG. Lymphedema following treatment for breast cancer: a new approach to an old problem. Crit Rev Oncol Hematol. 2013 Nov;88(2):437-46. doi: 10.1016/j.critrevonc.2013.05.001. Epub 2013 Jun 16.

    PMID: 23777977BACKGROUND

  • Cormier JN, Askew RL, Mungovan KS, Xing Y, Ross MI, Armer JM. Lymphedema beyond breast cancer: a systematic review and meta-analysis of cancer-related secondary lymphedema. Cancer. 2010 Nov 15;116(22):5138-49. doi: 10.1002/cncr.25458.

    PMID: 20665892BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
1. Study Group-Patient with Lymphedema 2. Control Group-Healthy Group
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 1. Working Group (Complex decongestive therapy) 2. Control Group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 26, 2024

Study Start

April 3, 2024

Primary Completion (Estimated)

April 3, 2027

Study Completion (Estimated)

April 3, 2028

Last Updated

September 24, 2024

Record last verified: 2024-09

Locations

TU(1)