Breast Cancer LymphedemaPLEDGE-SurgeryNCT05120180
Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
A study testing axillary lymph node dissection with vein branches reservation and axillary lymph node dissection without vein branches reservation in people with Breast Cancer Lymphedema, run by Xiangyun Zong at 3 sites in China.
Trial summary
The purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- axillary lymph node dissection with vein branches reservation and axillary lymph node dissection without vein branches reservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 3 sitesChina
- Study dates
- 3 Jan 2022to 1 Apr 2029
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-69 years old,
- Regardless of gender,
- Breast masses were diagnosed by histology and pathology, stage II -III.
- Clinical palpation of axillary lymph nodes is positive, or
- Axillary lymph node puncture pathology is positive, or
- The multidisciplinary treatment cooperation group (MDT) recommends axillary lymph node dissection,
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- Good physical state score (0-2),
- No severe organ complications,
- No congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs,
- Informed consent, understanding and compliance with research requirements.
Who cannot join
- Pregnancy or lactation,
- Inflammatory breast cancer,
- Clinical findings of metastatic lesions,
- Sentinel lymph node biopsy was negative,
- History of upper limb or shoulder, chest, back trauma or surgery,
- Previous history of local radiotherapy,
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- History of other tumors,
- Vascular embolic disease,
- Those who are unable to comply with the clinical trial requirements for any reason.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Shanghai Fengxian Central Hospital
Shanghai, 201499
About this study
Official title: Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision With or Without Axillary Vein Branches Reservation in Breast Cancer Patients: a Prospective, Multiple-center, Double-blinded, Randomized Controlled Study
The purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- axillary lymph node dissection with vein branches reservation, axillary lymph node dissection without vein branches reservation
- Keywords
- Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, Axillary Vein Branches Reservation
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary lymph node dissection with vein branches reservationProcedure or surgery
Spare the vein branches when ALND being performed
axillary lymph node dissection without vein branches reservationProcedure or surgery
Don't spare the vein branches when ALND being performed
| Study group | Role | What they receive |
|---|---|---|
| Branches Sparing | Experimental | The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches Receives: Procedure: axillary lymph node dissection with vein branches reservation |
| None Branches Sparing | Active comparator | The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches Receives: Procedure: axillary lymph node dissection without vein branches reservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term Incidence of lymphedema
short-term Incidence of upper limb lymphedema on affected side after operation
Measured: 1-, 6-, and 12-month
short-term Incidence of dysfunction
short-term Incidence of upper limb dysfunction on affected side after operation
Measured: 1-, 6-, and 12-month
Secondary outcomes (2)
long-term Incidence of lymphedema
long-term Incidence of upper limb lymphedema on affected side after operation
Measured: 5 yearsye
long-term Incidence of dysfunction
long-term Incidence of upper limb dysfunction on affected side after operation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start3 Jan 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangyun Zong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangyun Zong, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- XIANGYUN ZONG, M.D., Ph.D.P, Study chair, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120180
- Sponsor's protocol ID
- JTU-6H-20211011001
- Acronym
- PLEDGE-Surgery
- Status last verified
- Sep 2024
- First submitted
- 25 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision With or Without Axillary Vein Branches Reservation in Breast Cancer Patients: a Prospective, Multiple-center, Double-blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05120180
- Acronym / sponsor ID
- PLEDGE-Surgery / JTU-6H-20211011001
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, Axillary Vein Branches Reservation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Xiangyun ZongUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 15 Nov 2021 (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 purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branches Sparing | Experimental | Procedure: axillary lymph node dissection with vein branches reservationThe patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches |
| None Branches Sparing | Active comparator | Procedure: axillary lymph node dissection without vein branches reservationThe patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-69 years old,
- Regardless of gender,
- Breast masses were diagnosed by histology and pathology, stage II -III.
- Clinical palpation of axillary lymph nodes is positive, or
- Axillary lymph node puncture pathology is positive, or
Key exclusion criteria (9 listed)
- Pregnancy or lactation,
- Inflammatory breast cancer,
- Clinical findings of metastatic lesions,
- Sentinel lymph node biopsy was negative,
- History of upper limb or shoulder, chest, back trauma or surgery,
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 |
|---|---|---|
| axillary lymph node dissection with vein branches reservationSpare the vein branches when ALND being performed | Procedure or surgery | Branches Sparing |
| axillary lymph node dissection without vein branches reservationDon't spare the vein branches when ALND being performed | Procedure or surgery | None Branches Sparing |
Primary outcome
short-term Incidence of lymphedema
Time frame: 1-, 6-, and 12-month
short-term Incidence of upper limb lymphedema on affected side after operation
short-term Incidence of dysfunction
Time frame: 1-, 6-, and 12-month
short-term Incidence of upper limb dysfunction on affected side after operation
2 secondary outcomes
long-term Incidence of lymphedema
Time frame: 5 yearsye
long-term Incidence of dysfunction
Time frame: 5 years
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
XIANGYUN ZONG, M.D., Ph.D.P study chair
Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axillary lymph node dissection with vein branches reservation and axillary lymph node dissection without vein branches reservation in people with Breast Cancer Lymphedema, run by Xiangyun Zong at 3 sites 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 10 inclusion and 9 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
short-term Incidence of lymphedema (time frame: 1-, 6-, and 12-month). The study lists 2 primary outcomes in all. 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 19 Sep 2024.