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

January 14, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hang Zhou, Zhejiang, China, 310052
        • the Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Comprehensive detumescence treatment with education video
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
Active Comparator: 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.
Other: Comprehensive detumescence treatment
Three to five times a week, one hour each time

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at the first day and after one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
at the first day and after one month
Breast Cancer and Lymphedema Symptom Experience Index， BCLE-SEI
Time Frame: at the first day and after one month
at the first day and after one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • yan2024-1125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The primary outcome mesurement will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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