Evaluation of the Treatment Response in Breast Cancer Related Lymphedema

NCT ID: NCT04766489

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2019-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema of Upper Limb Breast Cancer Breast Cancer Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Complete Decongtestive Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Aggresive treatment phase for lymphedema

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Göksel Tanıgör M.D.

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University Faculty of Medicine

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 30291828 (View on PubMed)

Other Identifiers

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CLUE-BCL

Identifier Type: -

Identifier Source: org_study_id

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