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临床试验/NCT06572098
NCT06572098Enrolling By Invitation不适用

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

Baskent University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
52
试验地点
1
主要终点
PON1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Complex decongestive therapy (Other)

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.

结局指标

主要结局

PON1

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

Paraoxonase

次要结局

  • OSİ(will be assessed before treatment, immediately after treatment and one month after treatment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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