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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01521741
First received: September 6, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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
Lymphedema

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Upper extremity changes following treatment for breast cancer [ Time Frame: 1.5 to 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2500
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast Cancer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Newly diagnosed breast cancer patients.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521741

Locations
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
Investigators
Principal Investigator: Alphonse G Taghian, MD PhD Massachusetts General Hospital
  More Information

Publications:
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
Study First Received: September 6, 2011
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Breast Cancer
Lymphedema
symptoms

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

ClinicalTrials.gov processed this record on August 19, 2014