## Protocol Section
### Identification Module
**NCT ID:** NCT06415396

**Brief 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

**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

#### Organization Study ID Info
**ID:** 10025145
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2023-06-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-06-20

**Type:** ACTUAL

#### Start Date
**Date:** 2021-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara City Hospital Bilkent

#### Responsible Party

**Investigator Affiliation:** Ankara City Hospital Bilkent

**Investigator Full Name:** Bilge Büşra Ceylan

**Investigator Title:** Medical Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Lymphedema, Breast Cancer

**Keywords:**

- Lymphedema

- ESWT

- LLLT

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 66

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 22 breast cancer related lymphedema patients will received complete decongestive therapy

**Intervention Names:**

- Other: Complete Decongestive Therapy

**Label:** Complete Decongestive Therapy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Other: Complete Decongestive Therapy

- Device: ESWT

**Label:** Complete Decongestive Therapy and ESWT

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Other: Complete Decongestive Therapy

- Device: LLLT

**Label:** Complete Decongestive Therapy and LLLT

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Complete Decongestive Therapy

- Complete Decongestive Therapy and ESWT

- Complete Decongestive Therapy and LLLT

**Description:** 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.

**Name:** Complete Decongestive Therapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Complete Decongestive Therapy and ESWT

**Description:** 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. .

**Name:** ESWT

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Complete Decongestive Therapy and LLLT

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

**Name:** LLLT

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Upper limb Volume measured by perometer

**Measure:** Extremity volumes

**Time Frame:** Baseline, after three weeks

#### Secondary Outcomes

**Description:** quality of life questionnaire that is spesific for upper limb lymphedema

**Measure:** Lymphedema Quality of Life-arm (LYMQOL-arm )

**Time Frame:** Baseline, after three weeks

**Description:** questionnaire that shows functional status

**Measure:** Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

**Time Frame:** Baseline, after three weeks

**Description:** a straight line with one end meaning no pain and the other end meaning the worst pain imaginable

**Measure:** Visual Anologue Scale -Pain (VAS)

**Time Frame:** Baseline, after three weeks

### Eligibility Module

**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

**Gender Based:** True

**Gender Description:** we received female patients who had postmastectomy lymphedema

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital

**State:** Çankaya

**Zip:** 06800

#### Overall Officials

**Official 1:**

**Affiliation:** Ankara Bilkent City Hospital

**Name:** BilgeBüşra Ceylan, Medical Doctor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 36431224

**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.

**PMID:** 29216916

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: LOW

- As Found: Unknown

- ID: M11206

- Name: Lymphedema

- Relevance: HIGH

- As Found: Lymphedema

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: HIGH

- As Found: Pain Intensity

- ID: M1071

- Name: Breast Cancer Lymphedema

- Relevance: HIGH

- As Found: Lymphedema, Breast Cancer

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000008209

- Term: Lymphedema

- ID: D000072656

- Term: Breast Cancer Lymphedema

- ID: D000010146

- Term: Pain

### Misc Info Module

- Version Holder: 2024-05-31
