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OpenTrials
Active, Not Recruiting

NCT Number: NCT05056207

PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

Primary Objectives:

  • To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives:
  • To estimate the direct costs associated with the Lymphedema Screening Initiative
  • To determine the association of the Initiative on patient productivity
  • To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care
  • To determine patient understanding of lymphedema-associated symptoms
  • To determine patient self-reported compliance with treatments and measures to prevent lymphedema
  • To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a Cohort A:

  • Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection
  • English speaker
  • Patients who participate in Cohort A will be eligible for enrollment in Cohort

b Cohort I:

  • Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection
  • English speaker

c Cohort II:

  • Breast cancer patients who have undergone axillary lymph node dissection who are having a follow-up visit in the Nellie B. Connally Breast Center within 0-6 months following surgery who intend to continue follow-up care at MD Anderson
  • English speaker

Exclusion criteria

Inability to complete a self-administered questionnaire

Treatment and study plan

Cohort I (patients receiving annual lymphedema screening

Other

patientns who previously underwent preoperative perometer lymphedema screening

Cohort II (patients followed intensively for lymphedema)

Other

patients who have recently undergone ALND

Primary outcomes

  1. To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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