Lymphedema ArmNCT06783543
Efficacy of Home-based Treatment for Breast Cancer-related Lymphedema
A study testing Comprehensive detumescence treatment with education video and Comprehensive detumescence treatment in people with Lymphedema Arm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphedema Arm
- What is being tested?
- Comprehensive detumescence treatment with education video and Comprehensive detumescence treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2024to 13 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- People with severe cognitive impairment;
- Bilateral lymphedema;
- Patients undergoing radiotherapy；
- Patients with uncontrolled tumors;
- Congestive heart failure and other comprehensive detumescence treatment contraindicated patients.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
About this study
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.
Read the detailed description
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).
- Conditions
- Lymphedema Arm
- Being tested
- Comprehensive detumescence treatment with education video, Comprehensive detumescence treatment
- Keywords
- lymphedema, breast cancer, Manual therapy, home-based therapy
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive detumescence treatment with education videoOther
Also called Education video of manual lymphatic drainage and pressure bandaging
Comprehensive detumescence treatment, including skin care, manual lymphatic drainage, low elastic bandaging and functional exercise four steps
Comprehensive detumescence treatmentOther
Three to five times a week, one hour each time
| Study group | Role | What they receive |
|---|---|---|
| home-based group | Experimental | 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. Receives: Other: Comprehensive detumescence treatment with education video |
| outpatient group | Active comparator | 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. Receives: Other: Comprehensive detumescence treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the volum of affected arm
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.
Measured: at the first day and after one month
Secondary outcomes (2)
Quality of life Core questionnaire scale -- 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).
Measured: at the first day and after one month
Breast Cancer and Lymphedema Symptom Experience Index， BCLE-SEI
Measured: at the first day and after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start13 Nov 2024
- Primary completion13 Nov 2025 (estimated)
- Study completion13 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783543
- Sponsor's protocol ID
- yan2024-1125
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The primary outcome mesurement will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Home-based Treatment for Breast Cancer-related Lymphedema
- ClinicalTrials.gov ID
- NCT06783543
- Acronym / sponsor ID
- yan2024-1125
- Conditions
- Lymphedema Arm
- Keywords
- lymphedema, breast cancer, Manual therapy, home-based therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 13 Nov 2025 (estimated)
- Study completion
- 13 Dec 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| home-based group | Experimental | Other: Comprehensive detumescence treatment with education videoIn 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. |
| outpatient group | Active comparator | Other: Comprehensive detumescence treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (5 listed)
- People with severe cognitive impairment;
- Bilateral lymphedema;
- Patients undergoing radiotherapy；
- Patients with uncontrolled tumors;
- Congestive heart failure and other comprehensive detumescence treatment contraindicated patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive detumescence treatment with education videoAlso: Education video of manual lymphatic drainage and pressure bandagingComprehensive detumescence treatment, including skin care, manual lymphatic drainage, low elastic bandaging and functional exercise four steps | Other | home-based group |
| Comprehensive detumescence treatmentThree to five times a week, one hour each time | Other | outpatient group |
Primary outcome
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.
2 secondary outcomes
Quality of life Core questionnaire scale -- EORTC QLQ-C30
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Yes. The primary outcome mesurement will be shared.
Related trials for Lymphedema Arm
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive detumescence treatment with education video and Comprehensive detumescence treatment in people with Lymphedema Arm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the volum of affected arm (time frame: at the first day and after one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.