Clinical Trial: Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Study Groups:

If you agree to take part in this study, you will be assigned to one of two groups, depending on how long you have been receiving anastrozole treatment. If you are within two months prior to or one month after starting treatment, you will be assigned to Group 1 and you will be followed through 2 years of treatment. If you have been taking anastrozole for about 2 years, you will be assigned to Group 2 and you will be followed through your third year of treatment.

Study Procedures:

You will complete tests and procedures during your regularly scheduled clinic visits.

Assessment 1:

  • You will be taught how to use an automated symptom assessment program. For this program, a telephone system will call you at your home at a time that is convenient for you. Using the numeric key pad on your telephone, you will rate your pain and how it interferes with your daily activities.
  • You will complete questionnaires about your pain and other symptoms, quality of life, and your ability to work. Completing the questionnaires should take about 45 minutes.
  • You will also complete some cognitive (mental) questionnaires that should take about 30 minutes to complete. The cognitive questionnaires will be given to learn about problems with attention or mental fatigue that may be related to your treatment. If you choose not to complete the cognitive questionnaires, you can still participate in this study.
  • Blood (about 2 ½ tablespoons) will be drawn to learn about how certain proteins called cytokines (found in the blood) change during therapy. Researche
    Sponsor: M.D. Anderson Cancer Center

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

    Original Primary Outcome: To learn more about what it is like for patients with breast cancer to receive treatment with the drug anastrozole. [ Time Frame: 3 Years ]

    Current Secondary Outcome:

    Original Secondary Outcome:

    • Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. [ Time Frame: 3 Years ]
    • 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. [ Time Frame: 3 Years ]


    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: August 13, 2008
    Date Started: June 2008
    Date Completion:
    Last Updated: February 2, 2017
    Last Verified: February 2017