The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants

NCT ID: NCT06572098

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2028-04-03

Brief Summary

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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

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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.

Conditions

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What Are the Effects of Lymphedema Treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

1. Working Group (Complex decongestive therapy)
2. Control Group
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Complex decongestive therapy

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baskent University

Adana, çukurova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23777977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20665892 (View on PubMed)

Other Identifiers

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PDANALAN1

Identifier Type: -

Identifier Source: org_study_id

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