Clinical trial NCT01693731: Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Official title: Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Quality of Life
Keywords: Breast cancer
Periodontal Diseases
Aromatase Inhibitors
Oral Health Related Quality of Life
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2012-09-26
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will have a sample of 300 postmenopausal women; 150 healthy women and 150 with early breast cancer using Aromatase Inhibitors

Brief summary: 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.

Detailed description: OBJECTIVES:

Primary

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.

Secondary

* 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.

Eligibility criteria: Inclusion Criteria:

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.

AI users:

* 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.

Controls:

* No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of localized thyroid or skin cancer).

Exclusion Criteria:

Medical history

* 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.

Medications

* 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.)

Primary outcomes:
measure: Periodontal diseases
timeFrame: At the time of study visit
Secondary outcomes:
measure: Alveolar bone loss using salivary and serum-derived bone markers.
timeFrame: At the time of study visit
measure: Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire
timeFrame: At the time of study visit
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center For Oral Health Research (MCOHR)
state: Michigan
Study officials:
affiliation: University of Michigan
name: L. Susan Taichman, RDH MPH PhD
role: PRINCIPAL_INVESTIGATOR
References: