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The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants

The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants In Patıents Wıth Lymphedema After Breast Cancer Treatment

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06572098
Enrollment
52
Registered
2024-08-26
Start date
2024-04-03
Completion date
2028-04-03
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

What Are the Effects of Lymphedema Treatment

Keywords

Breast cancer, Lymphedema, Oxidative stress

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.

Detailed description

Lymphedema, which is the most common late complication of patients undergoing cancer treatment, affects the physical, social and psychological lives of the individual and decreases the quality of life as it causes motor dysfunctions, cosmetic deformations and psychological disorders. The addition of radiotherapy to surgical intervention increases the risk of lymphedema by 36%. When free radicals increase in intensity, they cause structural defects in lipids, proteins and nucleic acids, and as a result, they are a cause and risk factor for chronic diseases such as cancer, neurodegenerative diseases and cardiovascular diseases. Cancer cells produce high levels of reactive oxygen species (ROS) due to their fast metabolism and impaired cellular signaling mechanisms. High levels of ROS are generally harmful to cells and the redox state of cancer cells is different from normal cells. Therefore, cancer cells maintain ROS levels at a moderately high tumorigenic level, above the low cytostatic level, but below levels that may be cytotoxic. The oxidative stress state in a cancer cell is different from the oxidative stress state in a normal cell. It is also well known that increased oxidative stress and inflammation are associated with cancer risk. The number of studies investigating the effect of complex decongestive therapy, which is stated to be the most effective treatment method in the treatment of lymphedema, the most common complication after breast cancer treatment, on oxidative stress and antioxidant levels is quite limited. In this study, it was aimed to reveal the changes of complex decongestive therapy applications on oxidative stress parameters and antioxidants in participants with lymphedema after breast cancer treatment.

Interventions

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.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

1. Study Group-Patient with Lymphedema 2. Control Group-Healthy Group

Intervention model description

1. Working Group (Complex decongestive therapy) 2. Control Group

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
PON1will be assessed before treatment, immediately after treatment and one month after treatment.Paraoxonase

Secondary

MeasureTime frameDescription
OSİwill be assessed before treatment, immediately after treatment and one month after treatment.Oxidative Stress Index

Other

MeasureTime frameDescription
Trigliseritwill be assessed before treatment, immediately after treatment and one month after treatment.level of Trigliserit
LDLwill be assessed before treatment, immediately after treatment and one month after treatment.Low danditelilipoprotein
MDAwill be assessed before treatment, immediately after treatment and one month after treatment.malonDialdehyde
GSHwill be assessed before treatment, immediately after treatment and one month after treatment.Rduktegulutathion
HDLwill be assessed before treatment, immediately after treatment and one month after treatment.High densitelilipoprotein

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026