Breast Cancer and RehabilitationNCT05240235
The Effect of Manual Lymph Drainage in the Treatment of Breast Edema
A study testing Education, compression and exercise therapy and Education, compression and exercise therapy manual lymph drainage in people with Breast Cancer and Rehabilitation, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Breast conserving surgery (BCS) is widely used in the treatment of breast cancer. Breast edema can be seen frequently after BCS and radiotherapy applications. Breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer and Rehabilitation
- What is being tested?
- Education, compression and exercise therapy and Education, compression and exercise therapy manual lymph drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2023to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent breast-conserving surgery and received adjuvant radiotherapy
- Patients with Sentinel Lymph Node Biopsy or axillary lymph node dissection
- Female patients between the ages of 18-75
- Patients who cannot read and write Turkish
Who cannot join
- A previous cancer
- Decompensated heart failure
- Untreated congestive heart failure
- Active infection
- Uncontrolled hypertension
- Acute kidney failure
Show all 10Show fewer
- Patients with acute deep vein thrombosis
- Metastasis and/or recurrence during treatment
- Patients who have undergone another surgery related to the breast and chest area
- Patients who develop lymphedema in the upper extremity during therapy will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Manual Lymph Drainage in the Treatment of Breast Edema That May Occur in Patients Undergoing Breast-conserving Surgery and Adjuvant Radiotherapy-Randomized Controlled Study
Breast conserving surgery (BCS) is widely used in the treatment of breast cancer. Breast edema can be seen frequently after BCS and radiotherapy applications. Breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. Therefore, it is important to treat and prevent its development. In the light of this information, the present randomized controlled study aims to determine the effect of manual lymph drainage method in the treatment of breast edema in patients undergoing breast-conserving surgery and adjuvant radiotherapy.
- Conditions
- Breast Cancer and Rehabilitation
- Being tested
- Education, compression and exercise therapy, Education, compression and exercise therapy manual lymph drainage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, compression and exercise therapyOther
Education; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home.
Education, compression and exercise therapy manual lymph drainageOther
Education; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home. In addition, patients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Education, compression and exercise therapy | Active comparator | Patients will be given exercise therapy every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do home exercise at home for 10 minutes. Receives: Other: Education, compression and exercise therapy |
| Education, compression,exercise therapy and manual lymph drainage | Active comparator | Patients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes. Receives: Other: Education, compression and exercise therapy manual lymph drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
LENT-SOMA criteria in breast edema
Breast Cancer Conservative treatment core objective measurement. It has a score between 13-52 points. As the score increases, it is seen that breast edema worsens. A decrease in the score indicates improvement in breast edema.
Measured: Change from baseline LENT-SOMA criteria at 12 weeks
Breast edema questionnaire
Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points.
Measured: Change from baseline breast edema questionnaire at 12 weeks
Clinical features of breast cancer and breast edema
The presence of breast fibrosis or edema, teleangiectasia or dyspigmentation will be scored on a 4-point categorical scale. The scale will be in the range of 0-16 points, high scores will indicate worsening of breast edema, and low scores will indicate improvement.
Measured: Change from baseline clinical features of breast cancer and breast edema at 12 weeks
Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC- BR23
The EORTC-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.All scores will linearly transforme to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. More severe symptoms or problems are represented by high symptom scores or items.
Measured: Change from baseline Quality of life (EORTC- BR23) test at 12 weeks
Secondary outcomes (2)
Breast pain intensity will be measured with the Visual Analog Scale
The scale is 10 cm long and is applied by specifying a point on the vertical or horizontal line with two different ends (0 = no pain, 10 = the most severe pain) corresponding to the severity of pain felt by the patient.
Measured: Change from baseline Visual Analog Scale test at 12 weeks
Quality of life test (EORTC QOL-C30)
It includes 30 items that are grouped into five scales functional (physical, social, emotional functioning, cognitive and role), three scales of symptoms (fatigue, pain, nausea and vomiting), a global scale of health / quality of life and a number of related individual items with the symptoms of the disease and its treatment, as well as an item of economic impact. The answers to the items on the scales refer to "last week," except the patient's physical functioning scale whose time frame is the present. These answers they obey a Likert format, which ranges from 1 ("Not at all") and 4 ("A lot")
Measured: Change from baseline Quality of life test (EORTC QOL-C30) at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start21 Nov 2023
- Primary completion15 Jun 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer and RehabilitationStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240235
- Sponsor's protocol ID
- ATADEK-2023/18
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Lymph Drainage in the Treatment of Breast Edema That May Occur in Patients Undergoing Breast-conserving Surgery and Adjuvant Radiotherapy-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05240235
- Acronym / sponsor ID
- ATADEK-2023/18
- Conditions
- Breast Cancer and Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 15 Feb 2022 (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.
Breast conserving surgery (BCS) is widely used in the treatment of breast cancer. Breast edema can be seen frequently after BCS and radiotherapy applications. Breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. Therefore, it is important to treat and prevent its development. In the light of this information, the present randomized controlled study aims to determine the effect of manual lymph drainage method in the treatment of breast edema in patients undergoing breast-conserving surgery and adjuvant radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education, compression and exercise therapy | Active comparator | Other: Education, compression and exercise therapyPatients will be given exercise therapy every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do home exercise at home for 10 minutes. |
| Education, compression,exercise therapy and manual lymph drainage | Active comparator | Other: Education, compression and exercise therapy manual lymph drainagePatients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent breast-conserving surgery and received adjuvant radiotherapy
- Patients with Sentinel Lymph Node Biopsy or axillary lymph node dissection
- Female patients between the ages of 18-75
- Patients who cannot read and write Turkish
Key exclusion criteria (10 listed)
- A previous cancer
- Decompensated heart failure
- Untreated congestive heart failure
- Active infection
- Uncontrolled hypertension
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 |
|---|---|---|
| Education, compression and exercise therapyEducation; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home. | Other | Education, compression and exercise therapy |
| Education, compression and exercise therapy manual lymph drainageEducation; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home. In addition, patients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes. | Other | Education, compression,exercise therapy and manual lymph drainage |
Primary outcome
LENT-SOMA criteria in breast edema
Time frame: Change from baseline LENT-SOMA criteria at 12 weeks
Breast Cancer Conservative treatment core objective measurement. It has a score between 13-52 points. As the score increases, it is seen that breast edema worsens. A decrease in the score indicates improvement in breast edema.
Breast edema questionnaire
Time frame: Change from baseline breast edema questionnaire at 12 weeks
Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points.
Clinical features of breast cancer and breast edema
Time frame: Change from baseline clinical features of breast cancer and breast edema at 12 weeks
The presence of breast fibrosis or edema, teleangiectasia or dyspigmentation will be scored on a 4-point categorical scale. The scale will be in the range of 0-16 points, high scores will indicate worsening of breast edema, and low scores will indicate improvement.
Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC- BR23
Time frame: Change from baseline Quality of life (EORTC- BR23) test at 12 weeks
The EORTC-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.All scores will linearly transforme to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. More severe symptoms or problems are represented by high symptom scores or items.
2 secondary outcomes
Breast pain intensity will be measured with the Visual Analog Scale
Time frame: Change from baseline Visual Analog Scale test at 12 weeks
Quality of life test (EORTC QOL-C30)
Time frame: Change from baseline Quality of life test (EORTC QOL-C30) at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Education, compression and exercise therapy and Education, compression and exercise therapy manual lymph drainage in people with Breast Cancer and Rehabilitation, run by Acibadem 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 11 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LENT-SOMA criteria in breast edema (time frame: Change from baseline LENT-SOMA criteria at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024.