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

260 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment PREVENT for preventing lymphedema?

The PREVENT trial used bioimpedance spectroscopy (BIS) and tape measurement (TM) to monitor and intervene early in breast cancer-related lymphedema, suggesting that early detection and intervention can help manage the condition. Additionally, the Perometer, a tool used in the PREVENT treatment, is recognized for its accuracy and convenience in measuring limb volume, which is crucial for assessing lymphedema. ^{1 2 3 4 5}

Is the treatment in the Lymphedema Prevention Strategies trial generally safe for humans?

The research articles provided do not contain specific safety data for the treatment in the Lymphedema Prevention Strategies trial or its related names. ^{6 7 8 9 10}

How does this treatment for lymphedema differ from other treatments?

This treatment for lymphedema is unique because it focuses on early detection and intervention, using newer diagnostic tools like bioimpedance spectroscopy and perometry, which are more sensitive and allow for earlier management compared to traditional methods. ^{2 11 12 13 14}

Research Team

Simona F. Shaitelman

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

I had breast cancer surgery with lymph node removal and plan to follow up at MD Anderson within 6 months.

Exclusion Criteria

Inability to complete a self-administered questionnaire

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Axillary Treatment and Chronic Breast Cancer-Related Lymphedema: Implications for Prospective Surveillance and Intervention From a Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Agreement between dual energy X-ray absorptiometry and opto-electronic volumetry for measurement of forearm volume. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of breast cancer-related lymphedema (upper limb swelling) prevalence estimated using objective and subjective criteria and relationship with quality of life. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Measuring Limb Volume: Accuracy and Reliability of Tape Measurement Versus Perometer Measurement. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The problem of post-breast cancer lymphedema: impact and measurement issues. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Global problem of drug-induced hearing loss. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Preventive Pharmacovigilance: timely and precise prevention of adverse events through person-level patient screening and dose-level product surveillance. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The impact of early detection and intervention of breast cancer-related lymphedema: a systematic review. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. [2022]

13. China pubmed.ncbi.nlm.nih.gov

[PROGRESS OF TREATMENT AND PREVENTION OF BREAST CANCER RELATED LYMPHEDEMA]. [2018]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Lymphedema following treatment for breast cancer: a new approach to an old problem. [2021]