Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Completed
Conditions studied: Periodontal Disease, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT01693731
- Run by
- University of Michigan
- People needed
- 300
- Starts
- 2012-04-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-05-20
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.)
Where it is running
- Michigan Center For Oral Health Research (MCOHR) — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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