MDACC Study Summary 2006-1038

Study Summary
No. 2006-1038:.......Breast......Charles Cleeland......Symptom Research

Study Summary Title



Study Summary Number:	2006-1038

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

Physician

New Patient Referral



Name:	Charles Cleeland	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Symptom Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3470 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	Astra Zeneca

Phase of Study:	N/A	Return Visit:	N/A

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

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.

Study Objectives / Outcomes

Primary Objective
To describe the incidence, clinical course, and treatment of joint pain and other treatment-related symptoms and the effects of these symptoms on continuation of therapy in breast cancer patients undergoing adjuvant treatment with anastrozole by longitudinal assessment of joint pain and other symptoms from the beginning of anastrozole treatment through the end of three years of treatment.

Secondary Objective
To identify risk factors and potential biological markers of joint pain and other treatment-related symptoms in breast cancer patients receiving adjuvant treatment with anastrozole.

Hypotheses
1. The incidence of joint pain measured by a validated patient reported pain instrument will be greater than the approximately 20% that has been previously reported in the clinical trial literature.

2. Patients who have the fewer reports of joint pain and other treatment-related symptoms will be able to better tolerate and complete the prescribed course of adjuvant anastrozole treatment as measured by Morisky Medication Adherence Questionnaire.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	06/05/2008

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00738998
Study Information on Clinical Trials Registry (clinicaltrials.gov)