Lymphedema Risk After Biopsy for Cervical or Vulvar Cancer

Overseen By Vance Broach, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metastatic disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1026 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify individuals at risk of developing lower leg swelling, known as lymphedema, after a specific type of surgery for early-stage cervical or vulvar cancer. Researchers will gather information using questionnaires from participants who have undergone this surgery. They are particularly interested in those who have had sentinel lymph node biopsies, a procedure used to check for cancer spread. Suitable candidates for this study have had early-stage cervical or vulvar cancer surgery at Memorial Sloan Kettering between 2006 and 2022 and can read and understand English.

As an unphased trial, this study allows participants to contribute to important research that could help identify risk factors for lymphedema, potentially benefiting future patients.

Will I have to stop taking my current medications?

The study does not involve any treatment or investigational procedures, so it does not specify whether you need to stop taking your current medications.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to provide insights into lymphedema development after sentinel lymph node biopsy in cervical or vulvar cancer patients. Unlike the standard of care, which typically involves monitoring and treating lymphedema symptoms as they appear, this study uses questionnaires to gather patient-reported outcomes. By collecting data directly from patients, researchers hope to better understand the incidence and impact of lymphedema, potentially leading to improved management and preventative strategies. This could enhance patient quality of life by addressing lymphedema more proactively.

Who Is on the Research Team?

Mario Leitao, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage squamous cell carcinoma of the vulva.

°Early stage: Stage 1-2

Underwent primary surgery at our institution between January 2006 and December 2019.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants complete a questionnaire to report on lower extremity lymphedema after surgery

1 year

Up to two mailings/messages and two phone calls

Follow-up

Participants are monitored for the prevalence of lower extremity lymphedema

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Questionnaires

How Is the Trial Designed?

Group I: Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN) Experimental Treatment 1 Intervention

Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires. No other interventions are planned.

Group II: Standard lymphadenectomy(LND) alone Experimental Treatment 1 Intervention

Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires. No other interventions are planned.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+