PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Lymphedema Clinical Trial

Official title:

PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05056207
• Other study ID #: 2017-0639
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: November 17, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: November 17, 2026
• Est. primary completion date: November 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• Cohort I (patients receiving annual lymphedema screening
patientns who previously underwent preoperative perometer lymphedema screening
• Cohort II (patients followed intensively for lymphedema)
patients who have recently undergone ALND

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.		through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center