ClinicalTrials.gg
CompletedNCT07810036Updated Sep 11, 2026

Can Deep Fascial Thickness Predict Treatment Response in Patients With Postmastectomy Lymphedema? An Ultrasonographic Approach

An observational study in Postmastectomy Lymphedema, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
42
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 34 studies in Breast Cancer Lymphedema with a site in Turkey — 5 open to participants now, 7 under way, none of them phase 3. Breast Cancer Lymphedema · Turkey.

Enrollment
9th of 12
42 · median 56
Started
2025
with 3 others
Observational
12 of 34
1 open now
Registered
32nd of 34
by date

Among the 34 studies in Breast Cancer Lymphedema with a site in Turkey, this one is the 9th largest by enrollment of the 12 observational ones that give a count, is one of 4 that started in 2025, is one of 12 observational ones, and was the 32nd registered.

Breast Cancer Lymphedema

124 studies on the registry are indexed under Breast Cancer Lymphedema; 39 are open to participants now.

Browse Breast Cancer Lymphedema studies →

Open to participants now

5 of the 34 studies in Breast Cancer Lymphedema with a site in Turkey are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 24 Breast Cancer Lymphedema studies recruiting now, 8 (33%) set no upper age limit and 9 (38%) stop at 75 or younger; none take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · female.

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02

Study 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 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.

03

Conditions studied

  • Postmastectomy Lymphedema
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Probability sample

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.

Eligibility criteria

Inclusion Criteria:

  • Inclusion Criteria:

    • 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

Exclusion Criteria:

  • Exclusion Criteria:

    • 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
    • to decongestive therapy (e.g., severe cardiac failure, impaired consciousness)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
42 participants (actual)
Patient registry
No

Interventions

  • Proceduremanual lymphatic drainage

    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.

06

What researchers measure

Primary outcomes

  1. measurement of subcutan tissue and deep fascia thickness

    Time frame: 3 months

07

Study locations

1 site
  • Istanbul Physical Medicine and Rehabilitation
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2025 to primary completion in Jun 2026, 6 months.

Of 12 observational studies under Breast Cancer Lymphedema, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 9, 2026
StartActual
Nov 13, 2025
Primary completionActual
Jun 1, 2026
CompletionActual
Sep 1, 2026
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07810036
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Nov 13, 2025
Primary completion
Jun 1, 2026
Completion
Sep 1, 2026
Last update
Sep 11, 2026
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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