Effects of Extracorporeal Shock Wave Therapy (ESWT) and Low Intensity Laser Therapy (LLLT) Added to Complete Decongestive Therapy (CDT) on Extremity Volume, Pain Intensity, Functional Status and Quality of Life in Patients With Postmastectomy Stage 2 Lymphedema

NCT ID: NCT06415396

Last Updated: 2024-05-16

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-06-25

Brief Summary

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This study aimed to comparatively investigate the effects of ESWT and LLLT added to conventional CDT (which is the standard treatment for breast cancer-related lymphedema) on patients' limb volume, pain intensity, functional status and quality of life.

Detailed Description

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after being informed study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into three groups in conventional complet decongestive therapy (CDT) program, electrocorporeal shock wave therapy (ESWT) combined with CDT program and low level laser therapy (LLLT) combined with CDT program

Conditions

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Lymphedema, Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Complete Decongestive Therapy

22 breast cancer related lymphedema patients will received complete decongestive therapy

Group Type ACTIVE_COMPARATOR

Complete Decongestive Therapy

Intervention Type OTHER

conventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks.

Complete Decongestive Therapy and ESWT

22 breast cancer related lymphedema patients will received ESWT added complete decongestive therapy

Group Type ACTIVE_COMPARATOR

Complete Decongestive Therapy

Intervention Type OTHER

conventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks.

ESWT

Intervention Type DEVICE

ESWT was applied to the second group for a total of 5 sessions, 2 sessions in the first two weeks and 1 session in the last week. .

Complete Decongestive Therapy and LLLT

22 breast cancer related lymphedema patients will received LLLT added complete decongestive therapy

Group Type ACTIVE_COMPARATOR

Complete Decongestive Therapy

Intervention Type OTHER

conventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks.

LLLT

Intervention Type DEVICE

In the third group, LLLT was applied for a total of 9 sessions, 3 sessions per week, in addition to conventional CDT.

Interventions

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Complete Decongestive Therapy

conventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks.

Intervention Type OTHER

ESWT

ESWT was applied to the second group for a total of 5 sessions, 2 sessions in the first two weeks and 1 session in the last week. .

Intervention Type DEVICE

LLLT

In the third group, LLLT was applied for a total of 9 sessions, 3 sessions per week, in addition to conventional CDT.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female patients with unilateral lymphedema after breast cancer-related surgery Patients whose chemotherapy and radiotherapy protocols have been completed Patients with stage 2 lymphedema according to ISL staging

Exclusion Criteria

* Patients with arm edema before breast cancer

* Patients with ongoing chemotherapy and radiotherapy Those with metastatic breast cancer Patients with acute infection Patients with BMI \>35 Patients with pregnancy Patients who have previously received KDT Patients with active cancer Patients with recurrence or metastasis of breast cancer on follow-up imaging Those with decompensated heart failure Those with kidney failure Patients with liver failure Patients with a history of deep vein thrombosis in the last 3 months Those who are allergic to the dressing materials to be applied Patients with active infection or open wound on their extremities Those with cognitive impairment Patients with sensory deficits Immobilized patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Bilge Büşra Ceylan

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BilgeBüşra Ceylan, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Lee JH, Kim SB, Lee KW, Ha WW. Long-Term Effects of Extracorporeal Shock Wave Therapy on Breast Cancer-Related Lymphedema. J Clin Med. 2022 Nov 15;11(22):6747. doi: 10.3390/jcm11226747.

Reference Type BACKGROUND
PMID: 36431224 (View on PubMed)

Baxter GD, Liu L, Petrich S, Gisselman AS, Chapple C, Anders JJ, Tumilty S. Low level laser therapy (Photobiomodulation therapy) for breast cancer-related lymphedema: a systematic review. BMC Cancer. 2017 Dec 7;17(1):833. doi: 10.1186/s12885-017-3852-x.

Reference Type BACKGROUND
PMID: 29216916 (View on PubMed)

Other Identifiers

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10025145

Identifier Type: -

Identifier Source: org_study_id

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