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Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: August 13, 2008
Last updated: January 27, 2015
Last verified: January 2015

The goal of this research study is to learn more about what it is like for patients with breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. Researchers also want to learn more about which patients are most likely to have joint symptoms by looking at certain proteins from routine blood draw samples.

Condition Intervention
Breast Cancer
Behavioral: Questionnaire
Other: Phone Calls

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence, onset and severity of arthralgia during anastrozole treatment [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: June 2008
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Questionnaire and Telephone Assessments
Breast cancer patients assigned to one or two groups: Group 1) enrolled at beginning of anastrozole treatment; or Group 2) if beginning third year of anastrozole treatment.
Behavioral: Questionnaire
Questionnaires about pain and other symptoms, quality of life, and ability to work will be completed.
Other Name: Survey
Other: Phone Calls
A telephone system will call every 2 weeks so that you can rate your symptoms and how they interfere with daily activities. Each call will take about 5 minutes.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with early stage hormone receptor positive breast cancer who are at these 2 time points in their anastrozole treatment: 1) at the time period between two months prior or one month after beginning of their anastrozole treatment (Cohort 1); 2) patients within +/- 2 months of the beginning of the third year of anastrozole treatment (Cohort 2).
  2. Patients >= 18 years old.

Exclusion Criteria:

  1. Patients with metastatic disease.
  2. Patients who cannot complete the assessment tools.
  3. Patients without telephone access.
  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 identifier: NCT00738998

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Charles Cleeland, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00738998     History of Changes
Other Study ID Numbers: 2006-1038
Study First Received: August 13, 2008
Last Updated: January 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Aromatase Inhibitors
Symptom Assessment
Phone Call

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on March 03, 2015