Postmastectomy LymphedemaNCT07810036
Can Deep Fascial Thickness Predict Treatment Response in Patients With Postmastectomy Lymphedema? An Ultrasonographic Approach
An observational study of Postmastectomy Lymphedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Research and Literature Summary / References (The research summary must not exceed 250 words and must be written in a clear, easily understandable form.) Lymphedema is a chronic and progressive disease that develops as a result of the accumulation of protein-rich fluid in the interstitial tissue following disruption… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmastectomy Lymphedema
- What is being tested?
- manual lymphatic drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2025to 1 Sep 2026
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: This study will include 42 patients presenting to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital who have been diagnosed with post-mastectomy lymphedema.
Who may be able to join
- Women aged 18 years and older with clinically diagnosed upper extremity lymphedema
- Stage I-II lymphedema according to the International Society of Lymphology (ISL) staging system (early to moderate stage, without advanced fibrosis)
- History of breast cancer surgery including mastectomy and axillary lymph node dissection
- Lymphedema present for at least 3 months (stable chronic phase)
- Anatomy suitable for ultrasonographic measurement of deep fascia thickness
Who cannot join
- Active infection or cellulitis of the affected limb
- Stage III (advanced fibrotic) lymphedema
- Lymphedema secondary to other causes (e.g., venous insufficiency, rheumatologic disease)
- Systemic conditions that may cause edema, such as diabetic neuropathy, congestive heart failure, or renal disease
- Severe trauma or surgery affecting the upper extremity other than the lymphedema-related surgery
- Pregnancy
- Contraindications to decongestive therapy (e.g., severe cardiac failure, impaired consciousness)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation
Istanbul
About this study
Research and Literature Summary / References
(The research summary must not exceed 250 words and must be written in a clear, easily understandable form.)
Read more
Lymphedema is a chronic and progressive disease that develops as a result of the accumulation of protein-rich fluid in the interstitial tissue following disruption of lymphatic drainage. Lymphedema of the upper extremity seen after breast cancer treatment is the most frequently encountered form, and it causes loss of function, restriction of movement, and deterioration in quality of life. Manual lymphatic drainage (MLD), a component of complex decongestive therapy (CDT), is a method of proven efficacy in reducing skin and subcutaneous tissue thickness. Demonstrated that compression applied at different pressures produced a significant reduction in skin and subcutaneous tissue thickness and accelerated the resolution of edema.
High-resolution ultrasound is used as a reliable method for evaluating the skin, subcutaneous adipose tissue, and fascial structures in lymphedema.Reported that in patients with lymphedema there is thickening of the cutis and subcutaneous tissue, an increase in echogenicity, and structural changes in the fascial structures, and that these changes may show a regional distribution.
In another study by the same research group, it was determined that in patients with lymphedema the superficial and deep fasciae are thinner compared with healthy individuals. It was emphasized that this may be an important clue regarding the role of fascial structure in the development of lymphedema.
In this thesis study, the effect of MLD treatment on days 1 and 15 in patients with stage 1-2 lymphedema will be evaluated by ultrasound, and the relationship between changes in subcutaneous tissue thickness and deep fascia thickness will be investigated. The aim is thereby to objectively demonstrate the response given to treatment and to make clinical rehabilitation more individualized.
- Conditions
- Postmastectomy Lymphedema
- Being tested
- manual lymphatic drainage
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual lymphatic drainageProcedure or surgery
Manual lymphatic drainage (MLD) was applied by a physiotherapist experienced in lymphedema management. Sessions lasted [45] minutes and were performed 5 days per week for 3 weeks, for a total of 15 sessions. Treatment started with proximal clearing of the neck, contralateral axillary and inguinal nodes, followed by distal- to-proximal drainage of the affected upper limb. MLD was combined with multilayer short-stretch compression bandaging, skin care and remedial exercises as part of complete decongestive therapy.Limb circumference and ultrasonographic measurements of subcutaneous tissue and deep fascia thickness were obtained on day 1 and day 15.
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of subcutan tissue and deep fascia thickness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start13 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmastectomy LymphedemaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810036
- Sponsor's protocol ID
- 2025-68
- Status last verified
- Oct 2025
- First submitted
- 3 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Deep Fascial Thickness Predict Treatment Response in Patients With Postmastectomy Lymphedema? An Ultrasonographic Approach
- ClinicalTrials.gov ID
- NCT07810036
- Acronym / sponsor ID
- 2025-68
- Conditions
- Postmastectomy Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 9 Sep 2026 (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.
Research and Literature Summary / References
(The research summary must not exceed 250 words and must be written in a clear, easily understandable form.)
Lymphedema is a chronic and progressive disease that develops as a result of the accumulation of protein-rich fluid in the interstitial tissue following disruption of lymphatic drainage. Lymphedema of the upper extremity seen after breast cancer treatment is the most frequently encountered form, and it causes loss of function, restriction of movement, and deterioration in quality of life. Manual lymphatic drainage (MLD), a component of complex decongestive therapy (CDT), is a method of proven efficacy in reducing skin and subcutaneous tissue thickness. Demonstrated that compression applied at different pressures produced a significant reduction in skin and subcutaneous tissue thickness and accelerated the resolution of edema.
High-resolution ultrasound is used as a reliable method for evaluating the skin, subcutaneous adipose tissue, and fascial structures in lymphedema.Reported that in patients with lymphedema there is thickening of the cutis and subcutaneous tissue, an increase in echogenicity, and structural changes in the fascial structures, and that these changes may show a regional distribution.
In another study by the same research group, it was determined that in patients with lymphedema the superficial and deep fasciae are thinner compared with healthy individuals. It was emphasized that this may be an important clue regarding the role of fascial structure in the development of lymphedema.
In this thesis study, the effect of MLD treatment on days 1 and 15 in patients with stage 1-2 lymphedema will be evaluated by ultrasound, and the relationship between changes in subcutaneous tissue thickness and deep fascia thickness will be investigated. The aim is thereby to objectively demonstrate the response given to treatment and to make clinical rehabilitation more individualized.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- This study will include 42 patients presenting to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital who have been diagnosed with post-mastectomy lymphedema.
Key inclusion criteria (5 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| manual lymphatic drainageManual lymphatic drainage (MLD) was applied by a physiotherapist experienced in lymphedema management. Sessions lasted [45] minutes and were performed 5 days per week for 3 weeks, for a total of 15 sessions. Treatment started with proximal clearing of the neck, contralateral axillary and inguinal nodes, followed by distal- to-proximal drainage of the affected upper limb. MLD was combined with multilayer short-stretch compression bandaging, skin care and remedial exercises as part of complete decongestive therapy.Limb circumference and ultrasonographic measurements of subcutaneous tissue and deep fascia thickness were obtained on day 1 and day 15. | Procedure or surgery | – |
Primary outcome
measurement of subcutan tissue and deep fascia thickness
Time frame: 3 months
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 Sep 2026.
- 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?
An observational study of Postmastectomy Lymphedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 5 inclusion and 7 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 Sep 2026. 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?
measurement of subcutan tissue and deep fascia thickness (time frame: 3 months). 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 Sep 2026.