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

NCT ID: NCT05240235

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2024-07-10

Brief Summary

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.

Conditions

Breast Cancer and Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Education, compression and exercise therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Education, compression and exercise therapy manual lymph drainage

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Nuray Alaca

Assoc Prof. Nuray Alaca

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Acibadem University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ATADEK-2023/18

Identifier Type: -

Identifier Source: org_study_id