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NCT Number: NCT06572098

The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants

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.

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Adana, çukurova, 01250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complex Decongestive Therapy

Other

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.

Primary outcomes

  1. PON1

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

    Paraoxonase

Secondary outcomes

  1. OSİ

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

    Oxidative Stress Index

Other outcomes

  1. LDL

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

    Low danditelilipoprotein

  2. HDL

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

    High densitelilipoprotein

  3. Trigliserit

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

    level of Trigliserit

  4. GSH

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

    Rduktegulutathion

  5. MDA

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

    malonDialdehyde

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 26, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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