The Effect of Manual Lymph Drainage in the Treatment of Breast Edema

The Effect of Manual Lymph Drainage in the Treatment of Breast Edema That May Occur in Patients Undergoing Breast-conserving Surgery and Adjuvant Radiotherapy-Randomized Controlled Study

Breast conserving surgery (BCS) is widely used in the treatment of breast cancer. Breast edema can be seen frequently after BCS and radiotherapy applications. Breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. Therefore, it is important to treat and prevent its development. In the light of this information, the present randomized controlled study aims to determine the effect of manual lymph drainage method in the treatment of breast edema in patients undergoing breast-conserving surgery and adjuvant radiotherapy.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer and Rehabilitation
• Intervention / Treatment: Other: Education, compression and exercise therapy; Other: Education, compression and exercise therapy manual lymph drainage

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, +90
    • Recruiting
    • Acibadem University
    • Contact: Nuray ALACA; Phone Number: 05324251290; Email: nuray.alaca@acibadem.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients who underwent breast-conserving surgery and received adjuvant radiotherapy
2. Patients with Sentinel Lymph Node Biopsy or axillary lymph node dissection
3. Female patients between the ages of 18-75
4. Patients who cannot read and write Turkish

Exclusion Criteria:

1. A previous cancer
2. Decompensated heart failure
3. Untreated congestive heart failure
4. Active infection
5. Uncontrolled hypertension
6. Acute kidney failure
7. Patients with acute deep vein thrombosis
8. Metastasis and/or recurrence during treatment
9. Patients who have undergone another surgery related to the breast and chest area
10. Patients who develop lymphedema in the upper extremity during therapy will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Education, compression and exercise therapy; Patients will be given exercise therapy every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do home exercise at home for 10 minutes.	Other: Education, compression and exercise therapy; Education; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home.
Active Comparator: Education, compression,exercise therapy and manual lymph drainage; Patients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes.	Other: Education, compression and exercise therapy manual lymph drainage; Education; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home. In addition, patients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LENT-SOMA criteria in breast edema	Breast Cancer Conservative treatment core objective measurement. It has a score between 13-52 points. As the score increases, it is seen that breast edema worsens. A decrease in the score indicates improvement in breast edema.	Change from baseline LENT-SOMA criteria at 12 weeks
Breast edema questionnaire	Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points.	Change from baseline breast edema questionnaire at 12 weeks
Clinical features of breast cancer and breast edema	The presence of breast fibrosis or edema, teleangiectasia or dyspigmentation will be scored on a 4-point categorical scale. The scale will be in the range of 0-16 points, high scores will indicate worsening of breast edema, and low scores will indicate improvement.	Change from baseline clinical features of breast cancer and breast edema at 12 weeks
Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC- BR23	The EORTC-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.All scores will linearly transforme to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. More severe symptoms or problems are represented by high symptom scores or items.	Change from baseline Quality of life (EORTC- BR23) test at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast pain intensity will be measured with the Visual Analog Scale	The scale is 10 cm long and is applied by specifying a point on the vertical or horizontal line with two different ends (0 = no pain, 10 = the most severe pain) corresponding to the severity of pain felt by the patient.	Change from baseline Visual Analog Scale test at 12 weeks
Quality of life test (EORTC QOL-C30)	It includes 30 items that are grouped into five scales functional (physical, social, emotional functioning, cognitive and role), three scales of symptoms (fatigue, pain, nausea and vomiting), a global scale of health / quality of life and a number of related individual items with the symptoms of the disease and its treatment, as well as an item of economic impact. The answers to the items on the scales refer to "last week," except the patient's physical functioning scale whose time frame is the present. These answers they obey a Likert format, which ranges from 1 ("Not at all") and 4 ("A lot")	Change from baseline Quality of life test (EORTC QOL-C30) at 12 weeks

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ATADEK-2023/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No