search
Back to results

Evaluation of the Treatment Response in Breast Cancer Related Lymphedema

Primary Purpose

Lymphedema of Upper Limb, Breast Cancer, Breast Cancer Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Complete Decongtestive Therapy
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Upper Limb focused on measuring Lymphedema, Mastectomy, Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ege University Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Complete Deongestive Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 20, 2021
Last Updated
February 20, 2021
Sponsor
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT04766489
Brief Title
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema
Official Title
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema After Mastectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Limb, Breast Cancer, Breast Cancer Lymphedema
Keywords
Lymphedema, Mastectomy, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete Deongestive Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Complete Decongtestive Therapy
Other Intervention Name(s)
Aggresive treatment phase for lymphedema
Intervention Description
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.
Primary Outcome Measure Information:
Title
CLUE score
Description
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)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Hand Grip Strength
Description
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.
Time Frame
1 Month
Title
Extremity volume
Description
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.
Time Frame
1 Month
Title
Lymphedema index
Description
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.
Time Frame
1 Month
Title
QuickDASH
Description
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.
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ege University Faculty of Medicine
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans of sharing data.
Citations:
PubMed Identifier
30291828
Citation
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.
Results Reference
result

Learn more about this trial

Evaluation of the Treatment Response in Breast Cancer Related Lymphedema

We'll reach out to this number within 24 hrs