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Trial Title:
The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants
NCT ID:
NCT06572098
Condition:
What Are the Effects of Lymphedema Treatment
Conditions: Official terms:
Lymphedema
Conditions: Keywords:
Breast cancer
Lymphedema
Oxidative stress
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
1. Working Group (Complex decongestive therapy)
2. Control Group
Primary purpose:
Health Services Research
Masking:
Single (Participant)
Masking description:
1. Study Group-Patient with Lymphedema
2. Control Group-Healthy Group
Intervention:
Intervention type:
Other
Intervention name:
Complex decongestive therapy
Description:
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.
Arm group label:
working group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Female
Minimum age:
25 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Baskent University
Address:
City:
Adana
Zip:
01250
Country:
Turkey
Start date:
April 3, 2024
Completion date:
April 3, 2028
Lead sponsor:
Agency:
Baskent University
Agency class:
Other
Source:
Baskent University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572098
