What Are the Effects of Lymphedema TreatmentNCT06572098
The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants
A study testing Complex decongestive therapy in people with What Are the Effects of Lymphedema Treatment, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- What Are the Effects of Lymphedema Treatment
- What is being tested?
- Complex decongestive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2024to 3 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Development of lymphedema after breast cancer treatment
- Clinical stage of lymphedema Stage-2 or Stage-3 diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Complex decongestive therapy
- Keywords
- Breast cancer, Lymphedema, Oxidative stress
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex decongestive therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Complex decongestive therapy |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PON1
Paraoxonase
Measured: will be assessed before treatment, immediately after treatment and one month after treatment.
Secondary outcomes (1)
OSİ
Oxidative Stress Index
Measured: will be assessed before treatment, immediately after treatment and one month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start3 Apr 2024
- Primary completion3 Apr 2027 (estimated)
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for What Are the Effects of Lymphedema TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1. Working Group (Complex decongestive therapy) 2. Control Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572098
- Sponsor's protocol ID
- PDANALAN1
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23777977Cormier 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.
PubMed 20665892
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants In Patıents Wıth Lymphedema After Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT06572098
- Acronym / sponsor ID
- PDANALAN1
- Keywords
- Breast cancer, Lymphedema, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 3 Apr 2027 (estimated)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1. Working Group (Complex decongestive therapy) 2. Control Group
| Arm | Type | Receives |
|---|---|---|
| working group | Active comparator | Other: Complex decongestive therapyPatients 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. |
| 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Development of lymphedema after breast cancer treatment
- Clinical stage of lymphedema Stage-2 or Stage-3 diagnosis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex decongestive therapyComplex 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. | Other | working group |
Primary outcome
PON1
Time frame: will be assessed before treatment, immediately after treatment and one month after treatment.
Paraoxonase
1 secondary outcome
OSİ
Time frame: will be assessed before treatment, immediately after treatment and one month after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 23777977O'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.
- Background: PubMed 20665892Cormier 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex decongestive therapy in people with What Are the Effects of Lymphedema Treatment, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PON1 (time frame: will be assessed before treatment, immediately after treatment and one month after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.