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

Zhejiang University

Status: Active, not recruiting

Conditions: Lymphedema Arm

Treatments: Other: Comprehensive detumescence treatment; Other: Comprehensive detumescence treatment with education video

Study type: Interventional

Funder types: Other

Identifiers

NCT06783543

yan2024-1125

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

home-based group

Experimental group

Description:

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.

Treatment:

Other: Comprehensive detumescence treatment with education video

outpatient group

Active Comparator group

Description:

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.

Treatment:

Other: Comprehensive detumescence treatment