Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Vulvar Cancer; Cervical Cancer

Treatments: Other: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT05255393

22-002

Details and patient eligibility

About

The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure.

Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.

Enrollment: 111 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile.

  °Early stage: Stage 1-2

• Underwent primary surgery at our institution between January 2006 and January 2022.

• Alive at the time of study activation

• English comprehension

• Capable of providing informed consent

Exclusion criteria

• Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis

Trial design

111 participants in 2 patient groups

Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)

Description:

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.

Treatment:

Other: Questionnaires

Standard lymphadenectomy(LND) alone

Description:

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.

Treatment:

Other: Questionnaires