Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

• ClinicalTrials.gov Identifier: NCT01693731
• Recruitment Status: Completed
• First Posted: September 26, 2012
• Last Update Posted: May 20, 2015
• Sponsor: University of Michigan
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Information provided by (Responsible Party): Linda Susan Taichman, University of Michigan

Study Description

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.

Condition or disease
Periodontal Disease; Quality of Life

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 300 participants
• Time Perspective: Cross-Sectional
• Official Title: Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
• Study Start Date: April 2012
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Groups and Cohorts

Group/Cohort
Aromatase Inhibitor; Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
No Treatment; Healthy volunteer postmenopausal women not taking Aromatase Inhibitors

Outcome Measures

Primary Outcome Measures :

1. Periodontal diseases [ Time Frame: At the time of study visit ]

Secondary Outcome Measures :

1. Alveolar bone loss using salivary and serum-derived bone markers. [ Time Frame: At the time of study visit ]
2. Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire [ Time Frame: At the time of study visit ]

Biospecimen Retention:   Samples With DNA

Each patient will have 5ml of blood collected at the visit. Saliva, and urine will also be collected at the study visit.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• 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

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.)

Contacts and Locations

Locations

United States, Michigan

Michigan Center For Oral Health Research (MCOHR)

Ann Arbor, Michigan, United States, 48106

Sponsors and Collaborators

University of Michigan

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Principal Investigator: L. Susan Taichman, RDH MPH PhD; University of Michigan

More Information

• Responsible Party: Linda Susan Taichman, Principal Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT01693731 History of Changes
• Other Study ID Numbers: 5K23DEO21779; 5K23DE021779 ( U.S. NIH Grant/Contract ); HUM00048451 ( Other Identifier: UM MEDIRB )
• First Posted: September 26, 2012
• Last Update Posted: May 20, 2015
• Last Verified: May 2015

Keywords provided by Linda Susan Taichman, University of Michigan:

Breast cancer; Periodontal Diseases; Aromatase Inhibitors; Oral Health Related Quality of Life

Additional relevant MeSH terms:

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs