Ultrasonographic Evaluation of Changes After Complex Decongestive Therapy

NCT04139291 | Unknown

• 1 other identifier: 09.2019.866
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema of Upper Arm

Keywords

breast cancer related lymphedema; complex decongestive therapy; ultrasound

Outcome Measures

Primary Outcomes (6)

• Subcutaneous Echogenicity Grade (SEG) medial forearm (MFA)

  Medial forearm (MFA): from the medial side of the forearm to the brachioradial muscle

  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

  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.

  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.

  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

  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

  after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

Secondary Outcomes (32)

• Limb volume measurement

  before treatment (T0)

• Limb volume measurement

  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 Echo-Free Space Grade (SEFS) Medial upper arm (MUA)

  before treatment (T0)

• Subcutaneous tissue thickness measurement via ultrasound over medial upper arm (MUA)

  before treatment (T0)

Study Arms (1)

Patients with post-mastectomy lymphedema

EXPERIMENTAL

Patients with breast cancer related lymphedema

Other: Complex decongestive therapy phase 1

Interventions

Complex decongestive therapy phase 1 OTHER

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.

Patients with post-mastectomy lymphedema

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: women with breast cancer related lymphedema
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Esra Giray

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 28018504 RESULT

• 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.

  PMID: 31119909 RESULT

• 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.

  PMID: 30570358 RESULT

• 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.

  PMID: 29356592 RESULT

• 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.

  PMID: 30012444 RESULT

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Esra Giray

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Giray, MD

CONTACT

+902166570606162; girayesra@hotmail.com

Gulseren Akyuz, Prof

CONTACT

+902166570606162; gulserena@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The physiatrist who perform ultrasonographic assessments will be blind to other assessments.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with postmastectomy lymphedema

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 25, 2019
• Study Start: October 20, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 30, 2020
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)