Lymphedema Prevention Strategies

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Inability to complete questionnaire

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand breast cancer patients' opinions about screening for lymphedema, a condition where the arm can become heavy, painful, or swollen after breast cancer treatment. The trial evaluates a specific method called PREVENT (PeRomEter Visualization to ENd Treatment-related Lymphedema) to assess patient satisfaction. The study includes two groups: one group will undergo frequent screenings for lymphedema, while the other will be checked annually. This trial suits breast cancer patients who have had lymph node surgery and are receiving follow-up care at the MD Anderson center. As an unphased trial, it allows patients to contribute to research that could enhance post-treatment care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PREVENT program is safe for lymphedema screening?

Research has shown that lymphedema commonly occurs after breast cancer treatment. This condition causes an arm to become heavy, painful, or swollen due to fluid buildup. The PREVENT program uses a tool called a PeRomEter to address this issue. Studies indicate that early detection of lymphedema can significantly manage symptoms before they worsen.

The PREVENT tool serves as a screening device, not a medication, so no reports of side effects or adverse events exist. It aids in early identification of lymphedema, potentially improving quality of life. As a non-invasive screening tool, it poses no direct safety concerns like those associated with drugs or surgery.

The goal is to detect lymphedema early and reduce arm swelling. Studies have shown that patients find this screening helpful and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lymphedema Prevention Strategies because they focus on early detection and monitoring, which could lead to better management of lymphedema. Unlike traditional methods that often catch lymphedema after symptoms develop, the PREVENT approach uses PeRomEter visualization to identify changes before they become problematic. This proactive strategy could significantly reduce the severity of lymphedema by allowing for earlier intervention, potentially improving quality of life for patients who have undergone axillary lymph node dissection (ALND) for breast cancer. Additionally, the trial examines both intensive and annual screening methods, providing valuable insights into the most effective monitoring strategies.

What evidence suggests that the PREVENT program is effective for preventing lymphedema?

Research has shown that the PREVENT program, which uses a device called a perometer to measure arm size, can detect early signs of lymphedema. In this trial, participants in Cohort I will receive annual lymphedema screening, while those in Cohort II will undergo intensive monitoring for lymphedema. Past studies found that early detection with methods like bioimpedance spectroscopy and tape measurement allowed for timely treatments, reducing the risk of severe lymphedema. Early checks and monitoring have reduced symptoms like arm swelling and heaviness. Overall, starting screening early and conducting it thoroughly appears promising in preventing lymphedema in breast cancer patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Simona F. Shaitelman

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

The PREVENT trial is for English-speaking breast cancer patients who've had axillary lymph node dissection. It includes those with preoperative measurements (Cohort I) and those within 0-6 months post-surgery intending to continue follow-up at MD Anderson (Cohort II). Patients unable to complete a questionnaire are excluded.

Inclusion Criteria

Patients who participate in Cohort A will be eligible for enrollment in Cohort

I had surgery to remove lymph nodes due to breast cancer and visited the Nellie B. Connally Breast Center about a year later.

English speaker

Exclusion Criteria

Inability to complete a self-administered questionnaire

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Intensive Screening

Intensive lymphedema screening using a perometer for patients who have recently undergone ALND

1 year

Regular visits for screening

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Trial Overview

This study evaluates patient opinions on lymphedema screening, which detects swelling after breast cancer treatment. Cohort I receives annual screenings, while Cohort II has more intensive follow-ups. Patient satisfaction with the program is also assessed.

How Is the Trial Designed?

Group I: Cohort II (patients followed intensively for lymphedema) Experimental Treatment 1 Intervention

We will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening.

Group II: Cohort I (patients receiving annual lymphedema screening) Experimental Treatment 1 Intervention

We will retrospectively retrieve information on patients who previously underwent preoperative perometer lymphedema screening during the past year who were treated definitively for their breast cancer with an ALND, and for whom no follow-up postoperative lymphedema screening was done.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

AdEPro is an interactive app designed to simplify the exploration of adverse event data from clinical trials, allowing users to visualize data on individual subjects and treatment groups without needing extensive programming skills.

The app serves as a 'hypothesis generator' for users to quickly investigate questions about adverse events, such as their onset and severity, while ensuring that patient data is processed locally for privacy and security.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. Mentenich, N., Tasto, C., Becker, B.[2021]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05056207

PREVENT: PeRomEter Visualization to ENd Treatment ...

This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment)

2.

withpower.com

withpower.com/trial/phase-lymphedema-10-2017-a63bb

Lymphedema Prevention Strategies · Info for Participants

The PREVENT trial used bioimpedance spectroscopy (BIS) and tape measurement (TM) to monitor and intervene early in breast cancer-related lymphedema, suggesting ...

3.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05056207?keyword=%22Lymphedema%22

Lymphedema - San Mateo Clinical Trial PREVENT

Primary Objectives:~* To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0960977623000346

Prospective, early longitudinal assessment of lymphedema ...

We examined how breast cancer-related lymphedema (BCRL) affects health-related quality of life (HRQOL), productivity, and compliance with therapeutic ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11286467/

Comprehensive strategies in breast cancer-related ...

A lymphedema prevention program encompassing all these factors can significantly aid in preventing, treating, and reducing the severity of BCRL ...

6.

clinicaltrial.be

clinicaltrial.be/en/details/192689?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

PeRomEter Visualization to ENd Treatment-related...

To determine patient self-reported compliance with treatments and measures to prevent lymphedema; To determine the incidence of breast cancer- ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6107585/

Breast cancer-related lymphedema: risk factors, ...

Breast cancer-related lymphedema (BCRL) is a negative sequela of breast cancer treatment, and well-established risk factors include axillary lymph node ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4808814/

Recent Progress in Cancer-Related Lymphedema ...

This article provides an overview of the recent developments in the diagnosis, treatment, and prevention of cancer-related lymphedema.

9.

consultqd.clevelandclinic.org

consultqd.clevelandclinic.org/analysis-from-large-prospective-randomized-trial-finds-need-for-ongoing-lymphedema-surveillance

Ongoing lymphedema surveillance important after BC treatment

The PREVENT trial and this secondary analysis found patients continue to be at risk of BCRL years after surgery. In addition, early detection of ...