10000 Participants Needed

Screening for Lymphedema in Breast Cancer

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with breast cancer by assessing changes in arm health and quality of life during and after treatment. Researchers seek to identify early signs of lymphedema (swelling due to fluid buildup) to improve management. They will use bioimpedance spectroscopy, a special tool, to measure fluid in the upper body and evaluate its effectiveness for early screening of breast cancer-related lymphedema. This trial suits those diagnosed with breast cancer who can stand unaided and have no history of lymphedema. As an unphased trial, it offers a unique opportunity to contribute to early detection methods and enhance future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this screening method is safe for breast cancer patients?

Research shows that swelling from fluid build-up, known as lymphedema, can be a concern after breast cancer treatment. While the screening itself is safe and poses no risks, the condition it checks for can impact quality of life. Studies have found that the risk of lymphedema is higher soon after treatment, especially for those who underwent certain surgeries or radiation.

The screening process is safe and non-invasive, similar to getting measured or weighed. Its main goal is to detect any swelling early for more effective management. Importantly, no reports indicate negative effects from the screening itself, making it a safe and helpful way to monitor lymphedema after breast cancer treatment.12345

Why are researchers excited about this trial?

Researchers are excited about the screening for breast cancer-related lymphedema because it offers a proactive approach to managing this condition. Unlike current treatment options, which often involve managing symptoms after they appear, this screening method aims to detect lymphedema early, potentially preventing its progression. By catching the condition early, patients may have better outcomes with less invasive interventions, making this screening technique a promising development in patient care.

What evidence suggests that breast cancer-related lymphedema screening is effective for improving outcomes?

Research has shown that early screening for lymphedema, a condition related to breast cancer, can aid in earlier detection and management. This trial focuses on screening for breast cancer-related lymphedema. One study found that monitoring changes in arm size after breast cancer treatment can identify potential lymphedema, affecting up to 30% of survivors. Another study highlighted that certain screening methods, such as bioimpedance spectroscopy (BIS), can detect lymphedema earlier than other methods, potentially leading to better outcomes. Early detection through these screenings may help reduce symptoms and improve quality of life for those at risk.12467

Who Is on the Research Team?

AG

Alphonse G Taghian, MD PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Confirmed diagnosis of breast cancer
Ability to obtain physical positioning for perometry (e.g. abducting shoulder to 90 degrees) and BIS measurements (e.g. standing without aid)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline arm volume measurements and BIS measurements are taken, and a baseline questionnaire is filled out

1 visit
1 visit (in-person)

Treatment and Monitoring

Participants undergo treatment for breast cancer with periodic BCRL screening every 2-12 months depending on risk, including perometry and BIS measurements, and completion of questionnaires

1.5 to 5 years
Periodic visits (in-person)

Follow-up

Participants are monitored for changes in upper extremities and quality of life after treatment

1.5 to 5 years
Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Breast Cancer-Related Lymphedema Screening

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Breast CancerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Breast Cancer–Related Lymphedema: Risk Factors, ...

One study found that patients developing RVC increases of 3% to < 5% from baseline within 3 months of surgery or 5% to < 10% from baseline at any point after ...

Breast Cancer-Related Lymphedema: Risk Stratification ...

The cumulative incidence of BCRL (RVC ≥10%) at 1 year was 42%-52% via BIS and 14%-25% via RVC. These data indicate that BIS may overestimate ...

Prospective, early longitudinal assessment of lymphedema ...

With a median follow-up of 8 months in 247 patients, 46% self-reported ever having BCRL, a proportion that increased over time. About 73% ...

Preliminary Efficacy/Feasibility Study of a Breast Cancer ...

Lymphedema is one of the most common treatment-related adverse events experienced by breast cancer survivors [1]. Up to 30% [2] of the 4.1 million breast cancer ...

External Validation of a 5-Factor Risk Model for Breast ...

This prognostic study investigates the external validity of a 5-factor model for estimating 2-year lymphedema-free survival after treatment ...

Assessing breast cancer‐related lymphedema screening ...

Of those with BCRL, 58% received a PT/OT referral, and 56% completed their referral. There were no racial, insurance, or BMI category ...

NCT01521741 | Prospective Screening for Breast Cancer- ...

The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that ...