Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors
The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral conditions in postmenopausal early stage breast cancer survivors within the first 18 months of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life among postmenopausal early stage breast cancer survivors who are receiving AI therapy, (3) To determine the utilization of dental care among postmenopausal women receiving AIs with a history of early stage BCa over time. The hypothesis for this pilot study is that AIs negatively impact oral health and oral health quality of life in the setting of breast cancer survivors. Further, we hypothesize that dental visits are underutilized in women with BCa undergoing adjuvant AI therapy.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors|
- Periodontal diseases [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
- Oral health quality of life [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
• No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of thyroid or skin cancer).
This is a 2 arm prospective study. PM women receiving breast care, with and without breast cancer, at the University of Michigan are eligible. The study procedures include: survey/questionnaires, oral exam performed at Michigan Center for Oral Health Research (MCOHR) with specimen collection, and medical chart review. The goal of this study is to collect dental data and oral health quality of life data on women who are receiving AI therapy. This study does not administer any treatments or drugs to participants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272570
|United States, Michigan|
|Michigan Center for Oral Health Research|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Linda (Susan) Taichman, PhD||University of Michigan|