Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors
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Purpose
The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral conditions in postmenopausal early stage breast cancer survivors within the first 18 months of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life among postmenopausal early stage breast cancer survivors who are receiving AI therapy, (3) To determine the utilization of dental care among postmenopausal women receiving AIs with a history of early stage BCa over time. The hypothesis for this pilot study is that AIs negatively impact oral health and oral health quality of life in the setting of breast cancer survivors. Further, we hypothesize that dental visits are underutilized in women with BCa undergoing adjuvant AI therapy.
| Condition |
|---|
|
Breast Cancer Xerostomia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors |
- Periodontal diseases [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
- Oral health quality of life [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
whole saliva
| Estimated Enrollment: | 58 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
Aromatase Inhibitor
|
|
Control
• No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of thyroid or skin cancer).
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
29 postmenopausal women with a history of early stage BCa receiving adjuvant AI therapy and 29 postmenopausal women without cancer
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.
Controls:
-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 questionnaires
- 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| United States, Michigan | |
| Michigan Center for Oral Health Research | |
| Ann Arbor, Michigan, United States, 48106 | |
| Principal Investigator: | Linda (Susan) Taichman, PhD | University of Michigan |
More Information
Publications:
| Responsible Party: | Linda Susan Taichman, Assistant Professor of Dentistry, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01272570 History of Changes |
| Other Study ID Numbers: | HUM00036200 |
| Study First Received: | January 6, 2011 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
breast oral cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Xerostomia Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Salivary Gland Diseases |
Mouth Diseases Stomatognathic Diseases Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013