Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00738998
First received: August 13, 2008
Last updated: March 18, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Anastrozole
U.S. FDA Resources
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 2014 (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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
- Patients >= 18 years old.
Exclusion Criteria:
- Patients with metastatic disease.
- Patients who cannot complete the assessment tools.
- Patients without telephone access.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738998
Locations
| United States, Texas | |
| UT 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:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00738998 History of Changes |
| Other Study ID Numbers: | 2006-1038 |
| Study First Received: | August 13, 2008 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast Cancer Aromatase Inhibitors Symptom Assessment Questionnaire |
Survey Phone Call Arimidex Anastrozole |
Additional relevant MeSH terms:
|
Arthralgia Breast Neoplasms Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Anastrozole Aromatase Inhibitors Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013