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ICG-guided manual lymphatic drainage for Breast Cancer

N/A

Waitlist Available

Led By Lisa Spiguel, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial aims to study a new method of treating a condition called breast cancer related lymphedema (BCRL) that affects about 1 in 5 women who develop breast cancer. The current treatment

Who is the study for?

This trial is for breast cancer patients undergoing axillary node dissection. It's designed to see if a new type of manual lymphatic drainage (MLD) guided by indocyanine-green (ICG) imaging can help prevent lymphedema, which is swelling due to fluid build-up after breast cancer treatment.Check my eligibility

What is being tested?

The study compares two MLD techniques in preventing lymphedema: the new ICG-guided method that uses special imaging to tailor the massage to each patient's unique lymphatic system, and the traditional approach without such guidance.See study design

What are the potential side effects?

Since both interventions involve non-invasive massage techniques, side effects may be minimal but could include discomfort or mild pain at the site of drainage, skin irritation from ICG dye in sensitive individuals, or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Subject compliance

Secondary outcome measures

Bioimpedance

Breast cancer related lymphedema symptoms

Health-related quality of life

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ICG-guided manual lymphatic drainageExperimental Treatment1 Intervention

Group II: Traditional manual lymphatic drainageActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,627 Total Patients Enrolled

13 Trials studying Breast Cancer

561 Patients Enrolled for Breast Cancer

Lisa Spiguel, MDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

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

Is the inclusion criterion for this study set at a minimum age of 18 years?

"Enrollment in this research is open to individuals over 18 years old and under 99 years old."

Answered by AI

Is the enrollment for this study currently accepting new participants?

"As per clinicaltrials.gov, patient recruitment is not ongoing for this particular medical investigation. The trial was initially posted on June 1st, 2024 and last revised on March 18th, 2024. Despite the current inactivity, there are a multitude of other studies actively seeking participants - totaling to around 2700 opportunities at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer

2024. "A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06327490.