We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Prospective Analysis of Symptoms and Lymphedema in Patients Following Treatment for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01521741
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arm(s) during and after treatment for breast cancer. These problems are often associated with transient or chronic lymphedema, numbness, reduced shoulder flexibility, and an altered ability to use the arm for functional activities of daily living. The goal of this study is to collect data to support the hypothesis that swelling and other impairments in the upper extremities, causes a significant level of symptoms, functional disability and diminished quality of life for patients. Furthermore the investigators hope to evaluate how symptoms in the upper extremity (such as decreased functionality, sensory changes, pain or stiffness) are related to early, low volume lymphedema.

Condition or disease

Detailed Description:
The method that we propose for this trial is to administer a condensed form of the Lymphedema and Breast Cancer Questionnaire (LBCQ) , Disabilities of the Arm Shoulder and Hand (DASH) and Functional Assessment of Cancer Therapy- Breast quality of life instrument (FACT-B) as surveys/questionnaires within the clinic. This combined questionnaire is called the lymphedema evaluation following treatment for breast cancer (LEFT-BC). All patients who present for a baseline (pre-operative) arm measurement will be offered the opportunity to participate in this trial. At that point the purpose of the trial will be explained. Any patient that wishes to participate will be provided the questionnaires to complete and return (by mail or in person) to the study coordinator prior to surgery. During follow-up visits, questionnaires will be collected prior to perometer measurements and will be analyzed in conjunction with the measurements taken on the same day. We will utilize the questionnaires to evaluate their symptoms, functionality and quality of life (QOL). The perometer is a well-validated instrument and considered the gold standard today for quantifying volume in a limb. It is accurate to within a percent and far more accurate than circumferential measurement using a tape measure. It has been a regular part of the standard of care for MGH breast cancer patients. Patients are routinely measured at diagnosis, after surgery, after chemotherapy, after radiation, at four to six-month follow-up visits that continue for years, and anytime a patient reports with new symptoms of swelling or arm discomfort outside of these time frames.

Study Design

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.
Study Start Date : August 2009
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Breast Cancer

Outcome Measures

Primary Outcome Measures :
  1. Upper extremity changes following treatment for breast cancer [ Time Frame: 1.5 to 5 years ]
    During and following treatment for breast cancer patients' experience a variety of changes in their upper extremities. The subject responses to the LEFT-BC questionnaire obtained at the mandated study points will be analyzed in conjunction with a arm volume measurement. This will allow for the correlation between quantifiable limb volume changes and subject documented changes in arm use and functionality and quality of life.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed breast cancer patients.

Inclusion Criteria:

  • Confirmed diagnosis of breast cancer
  • No metastatic disease in the cervical or thoracic regions
  • No bulky disease in the thoracic or cervical region
  • No history of primary Lymphedema
  • No prior surgery to the head, neck, upper limb or trunk
  • No prior radiation to the head, neck, upper limb or trunk
  • No evidence of axillary lymph node malignancy causing Lymphedema due to recurrence

Exclusion Criteria:

  • metastatic or other locally advanced disease in the cervical or thoracic regions
  • known brain metastases
  • history of primary Lymphedema
  • history of prior surgery or radiation to the head, neck, upper limb or trunk
  • axillary lymph node malignancy causing Lymphedema (per physician discretion)
  • current case of cellulitis
  • history of a different malignancy except for the following: History of other malignancies if they are disease-free for 5+ years and deemed by the PI to be at low risk for recurrence OR <5 years of diagnosis and treatment for cervical cancer in situ, basal or squamous cell carcinoma of the skin.
  • Will not be returning routinely for follow-up at MGH or DFHCC
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521741

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02134
Contact: Alphonse G Taghian, MD PhD    617-726-6050    ataghian@partners.org   
Principal Investigator: Alphonse G Taghian, MD PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Alphonse G Taghian, MD PhD Massachusetts General Hospital
More Information

Responsible Party: Alphonse Taghian, MD, PhD, Chief of Breast Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01521741     History of Changes
Other Study ID Numbers: 08-540
R01CA139118 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alphonse Taghian, MD, PhD, Massachusetts General Hospital:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases