Clinical trial NCT04139291: Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy
Official title: Evaluation of Tissue Changes Via Ultrasound After Complex Decongestive Therapy Phase I for Breast Cancer Related Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema of Upper Arm
Keywords: breast cancer related lymphedema
complex decongestive therapy
ultrasound
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with postmastectomy lymphedema
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

-Patients with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)
timeFrame: before treatment (T0)
measure: Subcutaneous Echo-Free Space Grade (SEFS) medial forearm (MFA)
timeFrame: before treatment (T0)
measure: Subcutaneous tissue thickness measurement via ultrasound over medial forearm (MFA)
timeFrame: before treatment (T0)
measure: Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous Echo-Free Space Grade (SEFS) medial forearm (MFA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous tissue thickness measurement via ultrasound over medial forearm (MFA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Secondary outcomes:
measure: Limb volume measurement
timeFrame: before treatment (T0)
measure: Limb volume measurement
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous Echogenicity Grade (SEG) Medial upper arm (MUA)
timeFrame: before treatment (T0)
measure: Subcutaneous Echo-Free Space Grade (SEFS) Medial upper arm (MUA)
timeFrame: before treatment (T0)
measure: Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)
timeFrame: before treatment (T0)
measure: SEG grade of medial upper arm (MUA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous Echo-Free Space Grade (SEFS) Medial upper arm (MUA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous Echogenicity Grade (SEG) Lateral upper arm (LUA)
timeFrame: before treatment (T0)
measure: SEFS Lateral upper arm (LUA)
timeFrame: before treatment (T0)
measure: Subcutaneous tissue thickness measurement via ultrasound over lateral upper arm (LUA)
timeFrame: before treatment (T0)
measure: Subcutaneous Echogenicity Grade (SEG) Lateral upper arm (LUA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: SEFS Lateral upper arm (LUA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous tissue thickness measurement via ultrasound over lateral upper arm (LUA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous Echogenicity Grade (SEG) Lateral forearm (LFA)
timeFrame: before treatment (T0)
measure: SEFS Lateral forearm (LFA)
timeFrame: before treatment (T0)
measure: Subcutaneous tissue thickness measurement via ultrasound over lateral forearm (LFA)
timeFrame: before treatment (T0)
measure: SEG grade of lateral forearm (LFA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: SEFS Lateral forearm (LFA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous tissue thickness measurement via ultrasound over lateral forearm (LFA)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous Echogenicity Grade (SEG) Dorsum of the hand (DH)
timeFrame: before treatment (T0)
measure: SEFS Dorsum of the hand (DH)
timeFrame: before treatment (T0)
measure: Subcutaneous tissue thickness measurement via ultrasound over dorsum of the hand (DH)
timeFrame: before treatment (T0)
measure: SEG dorsum of the hand (DH)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: SEFS Dorsum of the hand (DH)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: SEG grade of Dorsum of the hand (DH)
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous Echogenicity Grade (SEG) wrist
timeFrame: before treatment (T0)
measure: SEFS wrist
timeFrame: before treatment (T0)
measure: Subcutaneous tissue thickness measurement via ultrasound over wrist
timeFrame: before treatment (T0)
measure: Subcutaneous Echogenicity Grade (SEG) wrist
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: SEFS wrist
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
measure: Subcutaneous tissue thickness measurement via ultrasound over wrist
timeFrame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Esra Giray
Study officials:
affiliation: Marmara University
name: Esra Giray
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Giray 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.
citation: Giray 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.
citation: Sezgin 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.
citation: Suehiro 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.