Lymphedema of Upper ArmNCT04139291
Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy
A study testing Complex decongestive therapy phase 1 in people with Lymphedema of Upper Arm, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema of Upper Arm
- What is being tested?
- Complex decongestive therapy phase 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2019to 30 Mar 2020
- 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 with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3
Who cannot join
- Bilateral lymphedema
- The patients who had known systemic edematogenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence
- Patients with contraindications for application of complex decongestive therapy (active cutaneous infection, deep vein thrombosis, cardiac edema, and peripheral artery disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Tissue Changes Via Ultrasound After Complex Decongestive Therapy Phase I for Breast Cancer Related Lymphedema
The aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy.
Read the detailed description
Lymphedema can be defined as the abnormal accumulation of protein-rich interstitial fluid that occurs primarily as a consequence of malformation, dysplasia, or acquired disruption of lymphatic circulation. Lymph stasis, which results in peripheral lymphedema, is characterized by edema and adipose tissue proliferation. As a vicious cycle of lymphedema progression, lymph stasis stimulates chronic inflammation because of uncontrolled responses of macrophages and CD4+ (cluster of differentiation 4) cells; fat accumulation also causes chronic inflammation by infiltration and activation of macrophages that produce inflammatory cytokines, which further promote lymph stasis directly or indirectly by decreasing lymphatic pumping and increasing capillary filtration. Lymphedema secondary to breast cancer is caused by the disruption of the lymphatic system, which in the initial stages leads to the accumulation of fluid in the interstitial tissue space and eventually is clinically presented as swelling of the arm, shoulder, neck, or torso. Complex decongestive physical therapy is a widely used nonoperative treatment of breast cancer-related lymphedema. The extremity volume has been one of the major parameters representing the treatment results of complex decongestive physical therapy. However, the increase in extremity volume in lymphedema can be caused both by tissue fluid accumulation and by pathologic tissue proliferation, which cannot be assessed separately at present. Accordingly, the volume or circumference measurement alone may not clarify how these phenomena are modified by complex decongestive physical therapy. Suehiro et al. developed subcutaneous echogenicity grade (SEG) and subcutaneous echo-free space (SEFS) grade via B-mode ultrasonography, allowing semiquantitation of nonspecific subcutaneous tissue inflammation and fluid accumulation. Increase in SEG is attributed to increased cell density and increased collagen content in the tissue and it is considered to indicate the presence of ongoing or previous inflammation in the area. SEFS represents the fluid accumulated in the spaces between superficial fasciae, which is freely mobile in the spaces. Recently, Suehiro et al. have investigated the impact of aggressive decongestion in limbs with lymphedema without SEFS in subcutaneous tissue ultrasonography. According to their results, the impact of aggressive decongestion seemed limited in patients with lymphedema without SEFS. But it was a retrospective study which may be a limitation to draw a firm conclusion. Therefore, the aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy.
- Conditions
- Lymphedema of Upper Arm
- Being tested
- Complex decongestive therapy phase 1
- Keywords
- breast cancer related lymphedema, complex decongestive therapy, ultrasound
- 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.
Complex decongestive therapy phase 1Other
Complex decongestive therapy-phase 1 program consist of meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist.
| Study group | Role | What they receive |
|---|---|---|
| Patients with post-mastectomy lymphedema | Experimental | Patients with breast cancer related lymphedema Receives: Other: Complex decongestive therapy phase 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle
Measured: before treatment (T0)
Subcutaneous Echo-Free Space Grade (SEFS) medial forearm (MFA)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over medial forearm (MFA)
SEG grade of medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)
SEG grade of medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echo-Free Space Grade (SEFS) medial forearm (MFA)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over medial forearm (MFA)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Secondary outcomes (32)
Limb volume measurement
Limb volume will be calculated based on truncated cone method from circumference measurements
Measured: before treatment (T0)
Limb volume measurement
Limb volume will be calculated based on truncated cone method from circumference measurements
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Medial upper arm (MUA)
SEG grade of medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
Subcutaneous Echo-Free Space Grade (SEFS) Medial upper arm (MUA)
Medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)
SEG grade of medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
SEG grade of medial upper arm (MUA)
SEG grade of medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echo-Free Space Grade (SEFS) Medial upper arm (MUA)
Medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)
Medial upper arm (MUA): from the medial side of the upper arm to the biceps brachii muscle
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Lateral upper arm (LUA)
SEG grade of lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
SEFS Lateral upper arm (LUA)
Lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over lateral upper arm (LUA)
SEG grade of lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
Subcutaneous Echogenicity Grade (SEG) Lateral upper arm (LUA)
SEG grade of lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS Lateral upper arm (LUA)
Lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over lateral upper arm (LUA)
SEG grade of lateral upper arm (LUA): from the lateral side of the upper arm to the biceps brachii muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Lateral forearm (LFA)
SEG grade of lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
SEFS Lateral forearm (LFA)
Lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over lateral forearm (LFA)
SEG grade of lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
SEG grade of lateral forearm (LFA)
SEG grade of lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS Lateral forearm (LFA)
Lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over lateral forearm (LFA)
Lateral forearm (LFA): from the lateral side of the forearm to the brachioradial muscle
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Dorsum of the hand (DH)
SEG grade of Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand.
Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
SEFS Dorsum of the hand (DH)
Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand. SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over dorsum of the hand (DH)
SEG grade of Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand.
Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
SEG dorsum of the hand (DH)
SEG grade of Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand.
Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS Dorsum of the hand (DH)
Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand. SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEG grade of Dorsum of the hand (DH)
Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand. SEG grade of Dorsum of the hand (DH): on the first dorsal interosseous muscle of the hand.
Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) wrist
SEG grade over wrist Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: before treatment (T0)
SEFS wrist
SEFS grade over wrist SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over wrist
Subcutaneous tissue thickness measurement via ultrasound over wrist
Measured: before treatment (T0)
Subcutaneous Echogenicity Grade (SEG) wrist
SEG grade over wrist Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS wrist
SEFS grade over wrist SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over wrist
Subcutaneous tissue thickness measurement via ultrasound over wrist
Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start20 Oct 2019 (estimated)
- Primary completion20 Mar 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of Upper ArmStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with postmastectomy lymphedema
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra Giray, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139291
- Sponsor's protocol ID
- 09.2019.866
- Status last verified
- Oct 2019
- First submitted
- 19 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators don't plan to share individual participant data (IPD) in public.
Publications
Suehiro K, Morikage N, Yamashita O, Harada T, Samura M, Takeuchi Y, Mizoguchi T, Nakamura K, Hamano K. Skin and Subcutaneous Tissue Ultrasonography Features in Breast Cancer-Related Lymphedema. Ann Vasc Dis. 2016;9(4):312-316. doi: 10.3400/avd.oa.16-00086. Epub 2016 Nov 25.
PubMed 28018504Giray E, Yagci I. Diagnostic accuracy of interlimb differences of ultrasonographic subcutaneous tissue thickness measurements in breast cancer-related arm lymphedema. Lymphology. 2019;52(1):1-10.
PubMed 31119909Giray E, Yagci I. Interrater and Intrarater Reliability of Subcutaneous Echogenicity Grade and Subcutaneous Echo-Free Space Grade in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2019 Oct;17(5):518-524. doi: 10.1089/lrb.2018.0053. Epub 2018 Dec 20.
PubMed 30570358Sezgin Ozcan D, Dalyan M, Unsal Delialioglu S, Duzlu U, Polat CS, Koseoglu BF. Complex Decongestive Therapy Enhances Upper Limb Functions in Patients with Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2018 Oct;16(5):446-452. doi: 10.1089/lrb.2017.0061. Epub 2018 Jan 22.
PubMed 29356592Suehiro K, Morikage N, Ueda K, Samura M, Takeuchi Y, Nagase T, Mizoguchi T, Hamano K. Aggressive Decongestion in Limbs with Lymphedema without Subcutaneous Echo-Free Space. Ann Vasc Surg. 2018 Nov;53:205-211. doi: 10.1016/j.avsg.2018.04.033. Epub 2018 Aug 9.
PubMed 30012444
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tissue Changes Via Ultrasound After Complex Decongestive Therapy Phase I for Breast Cancer Related Lymphedema
- ClinicalTrials.gov ID
- NCT04139291
- Acronym / sponsor ID
- 09.2019.866
- Conditions
- Lymphedema of Upper Arm
- Keywords
- breast cancer related lymphedema, complex decongestive therapy, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (estimated)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 25 Oct 2019 (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.
The aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy.
Detailed description
Lymphedema can be defined as the abnormal accumulation of protein-rich interstitial fluid that occurs primarily as a consequence of malformation, dysplasia, or acquired disruption of lymphatic circulation. Lymph stasis, which results in peripheral lymphedema, is characterized by edema and adipose tissue proliferation. As a vicious cycle of lymphedema progression, lymph stasis stimulates chronic inflammation because of uncontrolled responses of macrophages and CD4+ (cluster of differentiation 4) cells; fat accumulation also causes chronic inflammation by infiltration and activation of macrophages that produce inflammatory cytokines, which further promote lymph stasis directly or indirectly by decreasing lymphatic pumping and increasing capillary filtration. Lymphedema secondary to breast cancer is caused by the disruption of the lymphatic system, which in the initial stages leads to the accumulation of fluid in the interstitial tissue space and eventually is clinically presented as swelling of the arm, shoulder, neck, or torso. Complex decongestive physical therapy is a widely used nonoperative treatment of breast cancer-related lymphedema. The extremity volume has been one of the major parameters representing the treatment results of complex decongestive physical therapy. However, the increase in extremity volume in lymphedema can be caused both by tissue fluid accumulation and by pathologic tissue proliferation, which cannot be assessed separately at present. Accordingly, the volume or circumference measurement alone may not clarify how these phenomena are modified by complex decongestive physical therapy. Suehiro et al. developed subcutaneous echogenicity grade (SEG) and subcutaneous echo-free space (SEFS) grade via B-mode ultrasonography, allowing semiquantitation of nonspecific subcutaneous tissue inflammation and fluid accumulation. Increase in SEG is attributed to increased cell density and increased collagen content in the tissue and it is considered to indicate the presence of ongoing or previous inflammation in the area. SEFS represents the fluid accumulated in the spaces between superficial fasciae, which is freely mobile in the spaces. Recently, Suehiro et al. have investigated the impact of aggressive decongestion in limbs with lymphedema without SEFS in subcutaneous tissue ultrasonography. According to their results, the impact of aggressive decongestion seemed limited in patients with lymphedema without SEFS. But it was a retrospective study which may be a limitation to draw a firm conclusion. Therefore, the aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with postmastectomy lymphedema
| Arm | Type | Receives |
|---|---|---|
| Patients with post-mastectomy lymphedema | Experimental | Other: Complex decongestive therapy phase 1Patients with breast cancer related lymphedema |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3
Key exclusion criteria (3 listed)
- Bilateral lymphedema
- The patients who had known systemic edematogenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence
- Patients with contraindications for application of complex decongestive therapy (active cutaneous infection, deep vein thrombosis, cardiac edema, and peripheral artery 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 therapy phase 1Complex decongestive therapy-phase 1 program consist of meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist. | Other | Patients with post-mastectomy lymphedema |
Primary outcome
Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)
Time frame: before treatment (T0)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle
Subcutaneous Echo-Free Space Grade (SEFS) medial forearm (MFA)
Time frame: before treatment (T0)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Subcutaneous tissue thickness measurement via ultrasound over medial forearm (MFA)
Time frame: before treatment (T0)
SEG grade of medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEG grade of medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle Grade 0: No or little increase in echogenicity in the subcutaneous layer. Horizontal or obliquely oriented echogenic lines caused by connective tissue bundles are clearly observed. Grade 1: Diffused and monotonous increases in echogenicity in the subcutaneous layer. Echogenic lines are unclear but identifiable. Grade 2: Diffused increases in echogenicity. Echogenic lines are not identifiable.
Subcutaneous Echo-Free Space Grade (SEFS) medial forearm (MFA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle SEFS grade Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (‡45 degrees to the skin) SEFS bridging the horizontally oriented SEFS
Subcutaneous tissue thickness measurement via ultrasound over medial forearm (MFA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle
32 secondary outcomes
Limb volume measurement
Time frame: before treatment (T0)
Limb volume measurement
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Medial upper arm (MUA)
Time frame: before treatment (T0)
Subcutaneous Echo-Free Space Grade (SEFS) Medial upper arm (MUA)
Time frame: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)
Time frame: before treatment (T0)
SEG grade of medial upper arm (MUA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echo-Free Space Grade (SEFS) Medial upper arm (MUA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Lateral upper arm (LUA)
Time frame: before treatment (T0)
SEFS Lateral upper arm (LUA)
Time frame: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over lateral upper arm (LUA)
Time frame: before treatment (T0)
Subcutaneous Echogenicity Grade (SEG) Lateral upper arm (LUA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS Lateral upper arm (LUA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over lateral upper arm (LUA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Lateral forearm (LFA)
Time frame: before treatment (T0)
SEFS Lateral forearm (LFA)
Time frame: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over lateral forearm (LFA)
Time frame: before treatment (T0)
SEG grade of lateral forearm (LFA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS Lateral forearm (LFA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over lateral forearm (LFA)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) Dorsum of the hand (DH)
Time frame: before treatment (T0)
SEFS Dorsum of the hand (DH)
Time frame: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over dorsum of the hand (DH)
Time frame: before treatment (T0)
SEG dorsum of the hand (DH)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS Dorsum of the hand (DH)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEG grade of Dorsum of the hand (DH)
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous Echogenicity Grade (SEG) wrist
Time frame: before treatment (T0)
SEFS wrist
Time frame: before treatment (T0)
Subcutaneous tissue thickness measurement via ultrasound over wrist
Time frame: before treatment (T0)
Subcutaneous Echogenicity Grade (SEG) wrist
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
SEFS wrist
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Subcutaneous tissue thickness measurement via ultrasound over wrist
Time frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Results publication: PubMed 28018504Suehiro K, Morikage N, Yamashita O, Harada T, Samura M, Takeuchi Y, Mizoguchi T, Nakamura K, Hamano K. Skin and Subcutaneous Tissue Ultrasonography Features in Breast Cancer-Related Lymphedema. Ann Vasc Dis. 2016;9(4):312-316. doi: 10.3400/avd.oa.16-00086. Epub 2016 Nov 25.
- Results publication: PubMed 31119909Giray E, Yagci I. Diagnostic accuracy of interlimb differences of ultrasonographic subcutaneous tissue thickness measurements in breast cancer-related arm lymphedema. Lymphology. 2019;52(1):1-10.
- Results publication: PubMed 30570358Giray E, Yagci I. Interrater and Intrarater Reliability of Subcutaneous Echogenicity Grade and Subcutaneous Echo-Free Space Grade in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2019 Oct;17(5):518-524. doi: 10.1089/lrb.2018.0053. Epub 2018 Dec 20.
- Results publication: PubMed 29356592Sezgin Ozcan D, Dalyan M, Unsal Delialioglu S, Duzlu U, Polat CS, Koseoglu BF. Complex Decongestive Therapy Enhances Upper Limb Functions in Patients with Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2018 Oct;16(5):446-452. doi: 10.1089/lrb.2017.0061. Epub 2018 Jan 22.
- Results publication: PubMed 30012444Suehiro K, Morikage N, Ueda K, Samura M, Takeuchi Y, Nagase T, Mizoguchi T, Hamano K. Aggressive Decongestion in Limbs with Lymphedema without Subcutaneous Echo-Free Space. Ann Vasc Surg. 2018 Nov;53:205-211. doi: 10.1016/j.avsg.2018.04.033. Epub 2018 Aug 9.
- Individual participant dataSharing planned: No. The investigators don't plan to share individual participant data (IPD) in public.
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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.
Esra Giray principal investigator
Marmara University
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 phase 1 in people with Lymphedema of Upper Arm, run by Marmara 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Giray, MD (+902166570606162, girayesra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA) (time frame: before treatment (T0)). The study lists 6 primary outcomes in all. 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 NCT04139291, which also lists 5 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 25 Oct 2019.