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临床试验/NCT04139291
NCT04139291Unknown不适用

Evaluation of Tissue Changes Via Ultrasound After Complex Decongestive Therapy Phase I for Breast Cancer Related Lymphedema

Marmara University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)

研究概览

简要总结

The aim of this study is to evaluate tissue changes via ultrasound after complex decongestive therapy.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

The physiatrist who perform ultrasonographic assessments will be blind to other assessments.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究组 & 干预措施

Patients with post-mastectomy lymphedema

Experimental

Patients with breast cancer related lymphedema

干预措施: Complex decongestive therapy phase 1 (Other)

结局指标

主要结局

Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)

时间窗: 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)

时间窗: 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)

时间窗: 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

次要结局

  • Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous tissue thickness measurement via ultrasound over lateral forearm (LFA)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous tissue thickness measurement via ultrasound over wrist(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Limb volume measurement(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous Echogenicity Grade (SEG) Lateral forearm (LFA)(before treatment (T0))
  • SEFS Lateral forearm (LFA)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • SEG grade of lateral forearm (LFA)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous Echogenicity Grade (SEG) Medial upper arm (MUA)(before treatment (T0))
  • Subcutaneous Echogenicity Grade (SEG) Lateral upper arm (LUA)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • SEFS Lateral upper arm (LUA)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • SEG grade of Dorsum of the hand (DH)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous Echo-Free Space Grade (SEFS) Medial upper arm (MUA)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • SEG grade of medial upper arm (MUA)(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)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • SEFS Dorsum of the hand (DH)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous Echogenicity Grade (SEG) Dorsum of the hand (DH)(before treatment (T0))
  • SEG dorsum of the hand (DH)(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous Echogenicity Grade (SEG) wrist(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))
  • Subcutaneous tissue thickness measurement via ultrasound over dorsum of the hand (DH)(before treatment (T0))
  • SEFS wrist(after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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