The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants

Baskent University

Status: Invitation-only

Conditions: What Are the Effects of Lymphedema Treatment

Treatments: Other: Complex decongestive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06572098

PDANALAN1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

working group

Active Comparator group

Description:

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.

Treatment:

Other: Complex decongestive therapy

control group

No Intervention group

Description:

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.