Lymphedema Arm
Conditions
Keywords
lymphedema, breast cancer, Manual therapy, home-based therapy
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).
Interventions
OTHERComprehensive detumescence treatment with education video
Comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low elastic bandaging and functional exercise four steps
OTHERComprehensive detumescence treatment
Three to five times a week, one hour each time
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
According to the computer random number method, the enrolled patients were divided into home treatment group and outpatient treatment group, 20 cases each.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the volum of affected arm | at the first day and after one month | A soft ruler was used to measure the patient's wrist stripes and 10cm, 20cm, 30cm and 40cm above the wrist stripes, respectively, to obtain the circumference value. The five measurement points can divide the limb into four truncated cones, and then the formula can be used to calculate the volume of each limb segment, in which C1 and C2 are the arm circumference of the upper and lower two points of the measurement segment. h is the length of the measuring section, that is, 10 cm, and the whole limb volume is the sum of the volumes of each section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life Core questionnaire scale -- EORTC QLQ-C30 | at the first day and after one month | 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). |
| Breast Cancer and Lymphedema Symptom Experience Index， BCLE-SEI | at the first day and after one month | — |
Countries
China
Outcome results
None listed