Lower Extremity Lymphedema After Gynecologic Cancer SurgeryMLA-BMI-LLENCT07374835
BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema After Gynecologic Cancer Surgery
A study testing Meridian-Lymph Axis Based BMI Stratified Management and Routine Lymphatic Edema Care in people with Lower Extremity Lymphedema After Gynecologic Cancer Surgery, run by Hong Zhang at 1 site in China.
Trial summary
This study aims to investigate the impact of a BMI-stratified intervention program based on the meridian-lymphatic axis theory on the incidence of lower extremity lymphedema in postoperative patients with gynecological malignant tumors at 1 month, 3 months, and 6 months, and to validate the precision and effectiveness… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lower Extremity Lymphedema After Gynecologic Cancer Surgery
- What is being tested?
- Meridian-Lymph Axis Based BMI Stratified Management and Routine Lymphatic Edema Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 31 Dec 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Female patients aged 18-75 years who have undergone gynecologic cancer surgery (including hysterectomy, oophorectomy, or lymphadenectomy).
Diagnosed with lower extremity lymphedema (stage I-II) within 6 months to 2 years post-surgery, confirmed by circumferential measurement.
BMI between 18.5 and 35.0 kg/m². Able to understand and sign the informed consent form, and comply with the intervention and follow-up schedule.
No history of severe cardiovascular, renal, or hepatic dysfunction that would interfere with study participation.
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Exclusion Criteria:Patients with lower extremity lymphedema caused by other etiologies (e.g., trauma, infection, or congenital lymphedema).
History of lower extremity surgery or fracture within 3 months prior to enrollment.
Active infection or skin ulceration in the affected lower extremity. Participation in other clinical trials involving lymphedema interventions within the past 3 months.
Pregnancy or lactation during the study period. Inability to complete the intervention or follow-up due to cognitive or mobility impairment.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema in Patients After Gynecologic Cancer Surgery
This study aims to investigate the impact of a BMI-stratified intervention program based on the meridian-lymphatic axis theory on the incidence of lower extremity lymphedema in postoperative patients with gynecological malignant tumors at 1 month, 3 months, and 6 months, and to validate the precision and effectiveness of this program compared to traditional CDT. Primary objectives: to evaluate the effects of this program on reducing the incidence of lymphedema, alleviating lymphedema-related symptoms (assessed via GCLQ score), improving patients' quality of life (assessed via LLQoL score), and enhancing patients' self-management behaviors.
- Being tested
- Meridian-Lymph Axis Based BMI Stratified Management, Routine Lymphatic Edema Care
- Keywords
- Gynecologic Cancer Surgery, Lower Extremity Lymphedema, BMI Stratified Management, Meridian-Lymph Axis Theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meridian-Lymph Axis Based BMI Stratified ManagementOther
Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI.
Routine Lymphatic Edema CareOther
Standard care including compression garment use, limb elevation, and basic exercise guidance.
| Study group | Role | What they receive |
|---|---|---|
| BMI Stratified Management Group | Experimental | Participants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions. Receives: Other: Meridian-Lymph Axis Based BMI Stratified Management |
| Routine Care Control Group | Other | Participants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance). Receives: Other: Routine Lymphatic Edema Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method)
Limb volume change will be calculated using circumferential measurements of the lower extremity (ankle, calf, thigh) to quantify the reduction in lymphedema severity after intervention.
Measured: Baseline (before intervention), 12 weeks after intervention initiation
Change in Lower Extremity Lymphedema Volume (measured by circumferential measurement) from baseline to 12 weeks after intervention
Limb volume change will be calculated using circumferential measurements of the lower extremity to assess the efficacy of the intervention in reducing lymphedema.
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Change in Limb Function Score (using the Lymphoedema Functioning, Disability and Health Questionnaire, LYMPH-Q) from baseline to 12 weeks
Measured: baseline to 12 weeks
Change in Quality of Life Score (using the European Organization for Research and Treatment of Cancer QLQ-C30) from baseline to 12 weeks
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start9 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity Lymphedema After Gynecologic Cancer SurgeryStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374835
- Sponsor's protocol ID
- TJ-IRB202512073
- Acronym
- MLA-BMI-LLE
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Geng Y, Zhang H. Effect of BMI-stratified management based on the meridian-lymph axis theory on lower extremity lymphedema after gynecological cancer surgery: a randomized controlled trial. Front Oncol. 2026 Sep 24;16:1900880. doi: 10.3389/fonc.2026.1900880. eCollection 2026.
PubMed 42851494
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema in Patients After Gynecologic Cancer Surgery
- ClinicalTrials.gov ID
- NCT07374835
- Acronym / sponsor ID
- MLA-BMI-LLE / TJ-IRB202512073
- Keywords
- Gynecologic Cancer Surgery, Lower Extremity Lymphedema, BMI Stratified Management, Meridian-Lymph Axis Theory
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hong ZhangUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2026 (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.
This study aims to investigate the impact of a BMI-stratified intervention program based on the meridian-lymphatic axis theory on the incidence of lower extremity lymphedema in postoperative patients with gynecological malignant tumors at 1 month, 3 months, and 6 months, and to validate the precision and effectiveness of this program compared to traditional CDT. Primary objectives: to evaluate the effects of this program on reducing the incidence of lymphedema, alleviating lymphedema-related symptoms (assessed via GCLQ score), improving patients' quality of life (assessed via LLQoL score), and enhancing patients' self-management behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI Stratified Management Group | Experimental | Other: Meridian-Lymph Axis Based BMI Stratified ManagementParticipants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions. |
| Routine Care Control Group | Other | Other: Routine Lymphatic Edema CareParticipants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Meridian-Lymph Axis Based BMI Stratified ManagementPersonalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI. | Other | BMI Stratified Management Group |
| Routine Lymphatic Edema CareStandard care including compression garment use, limb elevation, and basic exercise guidance. | Other | Routine Care Control Group |
Primary outcome
Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method)
Time frame: Baseline (before intervention), 12 weeks after intervention initiation
Limb volume change will be calculated using circumferential measurements of the lower extremity (ankle, calf, thigh) to quantify the reduction in lymphedema severity after intervention.
Change in Lower Extremity Lymphedema Volume (measured by circumferential measurement) from baseline to 12 weeks after intervention
Time frame: Baseline, 12 weeks
Limb volume change will be calculated using circumferential measurements of the lower extremity to assess the efficacy of the intervention in reducing lymphedema.
2 secondary outcomes
Change in Limb Function Score (using the Lymphoedema Functioning, Disability and Health Questionnaire, LYMPH-Q) from baseline to 12 weeks
Time frame: baseline to 12 weeks
Change in Quality of Life Score (using the European Organization for Research and Treatment of Cancer QLQ-C30) from baseline to 12 weeks
Time frame: baseline to 12 weeks
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 29 Jan 2026.
- Derived from this study: PubMed 42851494Geng Y, Zhang H. Effect of BMI-stratified management based on the meridian-lymph axis theory on lower extremity lymphedema after gynecological cancer surgery: a randomized controlled trial. Front Oncol. 2026 Sep 24;16:1900880. doi: 10.3389/fonc.2026.1900880. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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.
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 Meridian-Lymph Axis Based BMI Stratified Management and Routine Lymphatic Edema Care in people with Lower Extremity Lymphedema After Gynecologic Cancer Surgery, run by Hong Zhang 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?
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: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. 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?
Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method) (time frame: Baseline (before intervention), 12 weeks after intervention initiation). 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?
On the ClinicalTrials.gov record for NCT07374835, which also lists 1 linked publication.
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 29 Jan 2026; AzTrials last refreshed its copy on 3 Nov 2026.