Clinical trial NCT06415396: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema, Breast Cancer
Keywords: Lymphedema
ESWT
LLLT
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Extremity volumes
timeFrame: Baseline, after three weeks
Secondary outcomes:
measure: Lymphedema Quality of Life-arm (LYMQOL-arm )
timeFrame: Baseline, after three weeks
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: Baseline, after three weeks
measure: Visual Anologue Scale -Pain (VAS)
timeFrame: Baseline, after three weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: BilgeBüşra Ceylan, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.