Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors

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. Identifier: NCT00738998
Recruitment Status : Active, not recruiting
First Posted : August 21, 2008
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Behavioral: Questionnaire Other: Phone Calls Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
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
Actual Study Start Date : June 2008
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Incidence, onset and severity of arthralgia during anastrozole treatment [ Time Frame: 3 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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 identifier (NCT number): 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00738998     History of Changes
Other Study ID Numbers: 2006-1038
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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