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Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738998
First Posted: August 21, 2008
Last Update Posted: February 3, 2017
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. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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: None (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 ]

Estimated Enrollment: 102
Study Start Date: June 2008
Estimated Primary Completion Date: June 2018 (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

  Eligibility

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
Criteria

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
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): NCT00738998


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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00738998     History of Changes
Other Study ID Numbers: 2006-1038
First Submitted: August 13, 2008
First Posted: August 21, 2008
Last Update Posted: February 3, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anastrozole
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs