Efficacy of Home-based Treatment for Breast Cancer-related Lymphedema

NCT ID: NCT06783543

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2025-12-13

Brief Summary

The goal of this clinical trials is to explore the effectiveness of home-based iymphedema treatment and the differences between the home-based and outpatient treatment. The main question is to verify that home-based treatment is as effective as outpatient treatment. We set two groups in this study, comparing the volume of affected upper limb to see if home-based iymphedema treatment is valuable method.

Detailed Description

Secondary outcome measures:

1. Core Quality of Life Questionnaire (EORTC QLQ-C30), It included five functional measures (somatic function, role function, cognitive function, emotional function, social function), three symptom measures (fatigue, pain, nausea and vomiting), six individual measures (dysphagia, loss of appetite, sleep disturbance, constipation, diarrhea, financial hardship), and one patient self-assessment item (total health status).

2. Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI).

Conditions

Lymphedema Arm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

home-based group

In this group of patients, the therapist conducted standardized comprehensive detumescence treatment at the first treatment which including four steps of skin care, manual lymphatic drainage, low-elastic bandage dressing and functional exercise. After the treatment, videos of manual lymphatic drainage and pressure dressing of family members were provided. Patients or family members were required to perform this treatment at home every day. Video recordings were necessary during treatment at home which were required be sent to the therapist, making sure the session is done every day. They returned to the edema clinic one month later for another evaluation. If patients encounter problems that cannot be solved during home treatment, they should consult online on wechat, or return to the edema clinic in time.

Group Type: EXPERIMENTAL

Comprehensive detumescence treatment with education video

Intervention Type: OTHER

Comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low elastic bandaging and functional exercise four steps

outpatient group

Patients were required to go to the lymphedema clinic for comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low-elastic bandaging and functional exercise, 3 to 5 times a week for 1 hour each time. They were re-evaluated after one month of treatment.

Group Type: ACTIVE_COMPARATOR

Comprehensive detumescence treatment

Intervention Type: OTHER

Three to five times a week, one hour each time

Interventions

Comprehensive detumescence treatment with education video

Comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low elastic bandaging and functional exercise four steps

Intervention Type: OTHER

Comprehensive detumescence treatment

Three to five times a week, one hour each time

Intervention Type: OTHER

Other Intervention Names

Education video of manual lymphatic drainage and pressure bandaging

Eligibility Criteria

Inclusion Criteria

1. Lymphedema appeared in the upper limb after breast cancer-related treatment, and compared with the healthy side, the edema dimension was more than 2cm.

2. Age 18-75 years old;

3. Edema stage Ⅰ to Ⅱ;

Exclusion Criteria

1. People with severe cognitive impairment;

2. Bilateral lymphedema;

3. Patients undergoing radiotherapy；

4. Patients with uncontrolled tumors;

5. Congestive heart failure and other comprehensive detumescence treatment contraindicated patients.

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

yan2024-1125

Identifier Type: -

Identifier Source: org_study_id