Evaluation of the Treatment Response in Breast Cancer Related Lymphedema

Evaluation of the Treatment Response in Breast Cancer Related Lymphedema After Mastectomy Surgery

This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Cancer Lymphedema; Lymphedema of Upper Limb
• Intervention / Treatment: Procedure: Complete Decongtestive Therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35100
      • Ege University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unilateral lymphedema of the arm after mastectomy for breast cancer

Exclusion Criteria:

• Bilateral lymphedema
• Primary bone tumor and/or metastasis
• Patients with ongoing radiotherapy
• Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis)
• Patients with infectious lymphedema/elephantiasis
• Presence of local infection in upper extremities(cellulitis) and/or presence of severe systemic infection
• Carcinomatous lymphangitis
• Congestive heart failure(NYHA class 3 or 4)
• History of prosthesis on upper extremities
• Use of drugs which may alter the fluid or electrolyte balance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Complete Deongestive Therapy; Patients will be given complete decongestive therapy for 5 days a week and for a mean of 20 sessions. Each session will be of approximately 2 hours and 15 minutes in duration, although short stretch bandaging will be left on for 23 hours a day.

Procedure: Complete Decongtestive Therapy; Patients will be given complete decongestive therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise, for 5 days a week and for a mean of 20 sessions. Each session will be of 1 hour duration for compressive therapies(Short stretch bandages will be left on for 23 hours a day), 30 minutes of manual lymphatic drainage, and decongestive exercises 3 times a day for 15 minutes each time.; Other Names: Aggresive treatment phase for lymphedema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLUE score	Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) is a standardized clinical evaluation tool which was developed to evaluate the severity of the lymphedema, especially in the context of clinical trials. CLUE involves assessing obscuration of anatomical architecture (eg, bony prominences, tendons), deviation from normal anatomical contour, change of soft-tissue texture, and the presence of pitting or nonpitting edema. It consists of these four assessments conducted in three different parts or the upper extremity(arm, forearm and hand). CLUE scores have a range of 0 to 72, with greater numbers associated with more severe lymphedema. It was shown to be valid and reliable for the assessment of breast cancer related lymphedema by Spinelli et al.(1)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Grip Strength	Hand grip strength: Hand grip strength will be measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients will be asked to sit down with shoulder adducted, elbow flexed (90°) and forearm in the neutral position. Mean of the 3 measurements taken with 1 minute apart from each other will be recorded. Patients' measurements will be taken for both affected and unaffected arm, and will be recorded as kgf.	1 Month
Extremity volume	Volume measurements will be taken using ulnar styloid process as a index point, and circumferential measurements were taken with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm will be calculated and recorded before and after the treatment for both arms. All patients' measurements will be taken by the same researcher, who happens to be experienced in this field.	1 Month
Lymphedema index	Lymphedema index will be acquired with a bioimpedance spectroscopy device (L-DEX U400, ImpediMed Limited, Brisbane-Australia). The device utilizes the characteristics of frequency dependent current flow to quantify changes in extracellular fluid in the patient's limb. The lymphedema index value increases on the scale with the higher levels of extracellular fluid, which is directly associated with the presence of lymphedema.	1 Month
QuickDASH	Short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire(Quick-DASH) will be used to assess the function of the upper extremities. The Quick-DASH contains 11 items (scored 1-5) and reflects both function and pain in persons with musculoskeletal disorders of the upper extremity. To be able to calculate a score, at least 10 of the 11 items must be completed. The overall score ranges from 0 to 100 points with higher score representing greater disability.	1 Month

Collaborators and Investigators

• Sponsor: Ege University

Publications and helpful links

General Publications

• Spinelli B, Kallan MJ, Zhang X, Cheville A, Troxel A, Cohn J, Dean L, Sturgeon K, Evangelista M, Zhang Z, Ebaugh D, Schmitz KH. Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity. Arch Phys Med Rehabil. 2019 Feb;100(2):315-326. doi: 10.1016/j.apmr.2018.08.185. Epub 2018 Oct 4.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Lymphedema; Breast Cancer; Mastectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: CLUE-BCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans of sharing data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No