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Procedure

Lymphedema Prevention Program for Breast Cancer

Phase 3

Recruiting

Led By Michelle Coriddi, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female sex

Ages 18 to 75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial tests if a program can help with lymph drainage & prevent lymphedema in breast cancer patients.

Who is the study for?

This trial is for women aged 18-75 with breast cancer who are undergoing or may undergo axillary lymph node dissection (ALND). They must be able to consent and speak English. It's not open to men, those allergic to ICG dye used in one of the procedures, patients needing bilateral ALND, those treated with SLNB only, have axillary recurrence or a history of ALND, or have impaired decision-making capacity.Check my eligibility

What is being tested?

The study tests a comprehensive prevention program that includes lymphatic massage, immediate lymphatic reconstruction surgery (ILR), volumetric arm measurements to track swelling, use of compression garments, and range-of-motion exercises. The goal is to see if these combined efforts can prevent lymphedema after breast cancer surgery.See study design

What are the potential side effects?

Potential side effects might include discomfort from massages or exercises and skin irritation from compression garments. Surgical risks involve typical postoperative complications like infection or adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am between 18 and 75 years old.

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I have agreed to undergo a specific type of lymph node removal surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The difference between the baseline and postoperative arm volume measurement

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Breast CancerExperimental Treatment5 Interventions

Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,613 Total Patients Enrolled

9 Trials studying Lymphedema

3,867 Patients Enrolled for Lymphedema

Michelle Coriddi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

180 Total Patients Enrolled

1 Trials studying Lymphedema

180 Patients Enrolled for Lymphedema

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed to this research?

"Affirmative. According to the information online on clinicaltrials.gov, this experiment is still seeking participants and was first posted on November 16th 2023 with an update also occurring that same day. Approximately 285 individuals need to be acquired from 7 different medical centres."

Answered by AI

How many locations are conducting this investigation?

"Presently, there are 7 sites recruiting for this research study across the country. These locations include Middletown, Montvale and Commack among others. It is recommended that those interested in participating select the nearest site to reduce their travel burden if accepted into this trial."

Answered by AI

Is enrollment currently open for this investigation?

"According to clinicaltrials.gov, this experiment is in need of volunteers. This trial was first advertised on November 16th 2023 and has since been updated once more also on the same day."

Answered by AI

Are adolescents within the accepted age range for this trial?

"This phase 3 trial is seeking participants aged 18-75."

Answered by AI

Who has the qualifications to be a participant in this experiment?

"To be accepted into this medical trial, potential participants should possess lymphedema and fit within the 18 to 75 year age bracket. There are a total of 285 spots available for enrolment."

Answered by AI

Has the FDA approved a treatment plan involving participants with Breast Cancer?

"Our Power team assessed the safety of participants with breast cancer to be a 3, due to existing evidence demonstrating efficacy and multiple assessments affirming its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer

2023. "A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144164.

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