Clinical trial · Observational
Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
NCT01693731CI-TRIAL-00017963completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Periodontal Disease | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Aromatase Inhibitor
- description
- Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
- label
- No Treatment
- description
- Healthy volunteer postmenopausal women not taking Aromatase Inhibitors
Primary outcomes (1)
- measure
- Periodontal diseases
- timeFrame
- At the time of study visit
Secondary outcomes (2)
- measure
- Alveolar bone loss using salivary and serum-derived bone markers.
- timeFrame
- At the time of study visit
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.