Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Verified February 2014 by University of Michigan
Information provided by (Responsible Party):
Linda Susan Taichman, University of Michigan
First received: September 18, 2012
Last updated: February 18, 2014
Last verified: February 2014
The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex, Aromasin or Femara affect a woman's oral health and oral health related quality of life. Patients, dental professionals and medical oncologists will benefit from a greater understanding of the best oral care follow up practices of breast cancer survivors using aromatase inhibitors.
Quality of Life
||Time Perspective: Cross-Sectional
||Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Primary Outcome Measures:
- Periodontal diseases [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- Alveolar bone loss using salivary and serum-derived bone markers. [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
- Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
Each patient will have 5ml of blood collected at the visit. Saliva, and urine will also be collected at the study visit.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
Healthy volunteer postmenopausal women not taking Aromatase Inhibitors
This cross-sectional prevalence study seeks to investigate the incidence and severity of oral health changes, specifically of periodontal conditions, among breast cancer survivors and the ways in which these outcomes affect their quality of life.
- To determine the prevalence and severity of oral conditions in postmenopausal women with early stage breast cancer using adjuvant AI therapy as compared to postmenopausal women not using adjuvant AI therapy.
- To determine if adjuvant AI therapy use is associated with greater alveolar bone loss or increased levels of bone turnover biomarkers in postmenopausal women with cancer undergoing adjuvant AI therapy compared to postmenopausal women not receiving AI therapy.
- To determine the oral health-related quality of life among postmenopausal women with early stage breast cancer who are receiving adjuvant AI therapy.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
This study will have a sample of 300 postmenopausal women; 150 healthy women and 150 with early breast cancer using Aromatase Inhibitors
Postmenopausal as defined by NCCN (any of the following)
- Prior bilateral oophorectomy
- Age equal to or greater then 60 years of age
- Age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifen or ovarian suppression and FSH and estradiol in the postmenopausal range
- If taking tamoxifen or toremifen and age less then 60y, then FSH and plasma estradiol level in postmenopausal ranges
Informed consent- Individuals capable of consenting and self administering the survey instrument Dentate- At least 15 teeth present.
- Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease.
- Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole) > 1 month. Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study.
- No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of localized thyroid or skin cancer).
- Metastatic BCa (AI treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).
- Significant psychiatric illness/social situations that would preclude completion of questionnaire.
- Chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). NSAIDS and bisphosphonates are permitted.
- Premedication- Conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (Patients taking prophylaxis for joint replacements will not be excluded.)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693731
|Contact: Tina Lucas, BA
|Contact: Susan Taichman, RDH MPH PhD
|Michigan Center For Oral Health Research (MCOHR)
|Ann Arbor, Michigan, United States, 48106 |
University of Michigan
||L. Susan Taichman, RDH MPH PhD
||University of Michigan
No publications provided
||Linda Susan Taichman, Principal Investigator, University of Michigan
History of Changes
|Other Study ID Numbers:
||5K23DEO21779, 5K23DE021779, HUM00048451
|Study First Received:
||September 18, 2012
||February 18, 2014
||United States: Institutional Review Board
Keywords provided by University of Michigan:
Oral Health Related Quality of Life
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
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Molecular Mechanisms of Pharmacological Action