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Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors

50 Years
Open (Enrolling)
Breast Cancer, Xerostomia

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Trial Information

Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors

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.

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, toremifene or ovarian suppression and FSH and estradiol
in the postmenopausal range

- If taking tamoxifen or toremifene and age less then 60y, then FSH and plasma
estradiol level in postmenopausal ranges71.

- Individuals capable of consenting and self administering the survey instrument.

- 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). 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 as long as the past therapy did not exceed 12 months
and the current therapy has not exceeded 12 months.


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

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Periodontal diseases

Outcome Time Frame:

At the time of study visit

Safety Issue:


Principal Investigator

Linda (Susan) Taichman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Xerostomia
  • breast
  • oral
  • cancer
  • Breast Neoplasms
  • Xerostomia



Michigan Center for Oral Health Research Ann Arbor, Michigan  48106