Clinical trial NCT06572098: The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants
Official title: The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants In Patıents Wıth Lymphedema After Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: What Are the Effects of Lymphedema Treatment
Keywords: Breast cancer
Lymphedema
Oxidative stress
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 52
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Working Group (Complex decongestive therapy)
2. Control Group
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: PON1
timeFrame: will be assessed before treatment, immediately after treatment and one month after treatment.
Secondary outcomes:
measure: OSİ
timeFrame: will be assessed before treatment, immediately after treatment and one month after treatment.
Other outcomes:
measure: LDL
timeFrame: will be assessed before treatment, immediately after treatment and one month after treatment.
measure: HDL
timeFrame: will be assessed before treatment, immediately after treatment and one month after treatment.
measure: Trigliserit
timeFrame: will be assessed before treatment, immediately after treatment and one month after treatment.
measure: GSH
timeFrame: will be assessed before treatment, immediately after treatment and one month after treatment.
measure: MDA
timeFrame: will be assessed before treatment, immediately after treatment and one month after treatment.
Locations:
city: Adana
country: Turkey
facility: Baskent University
state: Çukurova
Study officials:
References:
citation: O'Toole J, Jammallo LS, Skolny MN, Miller CL, Elliott K, Specht MC, Taghian AG. Lymphedema following treatment for breast cancer: a new approach to an old problem. Crit Rev Oncol Hematol. 2013 Nov;88(2):437-46. doi: 10.1016/j.critrevonc.2013.05.001. Epub 2013 Jun 16.
citation: Cormier JN, Askew RL, Mungovan KS, Xing Y, Ross MI, Armer JM. Lymphedema beyond breast cancer: a systematic review and meta-analysis of cancer-related secondary lymphedema. Cancer. 2010 Nov 15;116(22):5138-49. doi: 10.1002/cncr.25458.