The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: What Are the Effects of Lymphedema Treatment
• Intervention / Treatment: Other: Complex decongestive therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çukurova
    • Adana, Çukurova, Turkey, 01250
      • Baskent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: working group; 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.	Other: Complex decongestive therapy; 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.
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PON1	Paraoxonase	will be assessed before treatment, immediately after treatment and one month after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSİ	Oxidative Stress Index	will be assessed before treatment, immediately after treatment and one month after treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL	Low danditelilipoprotein	will be assessed before treatment, immediately after treatment and one month after treatment.
HDL	High densitelilipoprotein	will be assessed before treatment, immediately after treatment and one month after treatment.
Trigliserit	level of Trigliserit	will be assessed before treatment, immediately after treatment and one month after treatment.
GSH	Rduktegulutathion	will be assessed before treatment, immediately after treatment and one month after treatment.
MDA	malonDialdehyde	will be assessed before treatment, immediately after treatment and one month after treatment.

Collaborators and Investigators

• Sponsor: Baskent University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): April 3, 2028

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Oxidative stress; Lymphedema; Breast cancer
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: PDANALAN1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No