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NCT Number: NCT06783543

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphedema Arm Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

About this study

Secondary outcome measures:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lymphedema appeared in the upper limb after breast cancer-related treatment, and compared with the healthy side, the edema dimension was more than 2cm.
  • Age 18-75 years old;
  • Edema stage Ⅰ to Ⅱ;

Exclusion criteria

  • People with severe cognitive impairment;
  • Bilateral lymphedema;
  • Patients undergoing radiotherapy；
  • Patients with uncontrolled tumors;
  • Congestive heart failure and other comprehensive detumescence treatment contraindicated patients.

Treatment and study plan

Comprehensive detumescence treatment with education video

Other

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

Other names: Education video of manual lymphatic drainage and pressure bandaging

Comprehensive detumescence treatment

Other

Three to five times a week, one hour each time

Primary outcomes

  1. the volum of affected arm

    Time frame: 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 outcomes

  1. Quality of life Core questionnaire scale -- EORTC QLQ-C30

    Time frame: 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).

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

    Time frame: at the first day and after one month

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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