Evaluation of the Treatment Response in Breast Cancer Related Lymphedema

NCT04766489 | Completed

• 1 other identifier: CLUE-BCL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema of Upper Limb; Breast Cancer; Breast Cancer Lymphedema

Keywords

Lymphedema; Mastectomy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hand Grip Strength

  1 Month

• Extremity volume

  1 Month

• Lymphedema index

  1 Month

• QuickDASH

  1 Month

Study Arms (1)

Complete Deongestive Therapy

EXPERIMENTAL

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

Interventions

Complete Decongtestive Therapy PROCEDURE

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.

Also known as: Aggresive treatment phase for lymphedema

Complete Deongestive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral lymphedema of the arm after mastectomy for breast cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30291828 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer Lymphedema; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 23, 2021
• Study Start: July 11, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)