- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272570
Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors
May 26, 2015 updated by: Linda Susan Taichman, University of Michigan
Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48106
- Michigan Center for Oral Health Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
29 postmenopausal women with a history of early stage BCa receiving adjuvant AI therapy and 29 postmenopausal women without cancer
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Aromatase Inhibitor
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Control
• No Diagnosis of cancer.-
Patients must not have a diagnosis of any cancer (Not including a history of thyroid or skin cancer).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Periodontal diseases
Time Frame: At the time of study visit
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At the time of study visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Oral health quality of life
Time Frame: At the time of study visit
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At the time of study visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Linda (Susan) Taichman, PhD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ries LA YJ, Keel GE, Eisner MP, Lin YD, Horner MJ. SEER Survival Monograph: Cancer Survival Among Adults: U.S. SEER Program, 1988-2001, Patient and Tumor Characteristics. . , Bethesda, MD,: National Cancer Institute, SEER Program, ; 2007.
- Sonis ST, Fey EG. Oral complications of cancer therapy. Oncology (Williston Park). 2002 May;16(5):680-6; discussion 686, 691-2, 695.
- Stokman MA, Sonis ST, Dijkstra PU, Burgerhof JG, Spijkervet FK. Assessment of oral mucositis in clinical trials: impact of training on evaluators in a multi-centre trial. Eur J Cancer. 2005 Aug;41(12):1735-8. doi: 10.1016/j.ejca.2005.04.030.
- Ohrn KE, Wahlin YB, Sjoden PO. Oral status during radiotherapy and chemotherapy: a descriptive study of patient experiences and the occurrence of oral complications. Support Care Cancer. 2001 Jun;9(4):247-57. doi: 10.1007/s005200000214.
- Anderson WF, Chatterjee N, Ershler WB, Brawley OW. Estrogen receptor breast cancer phenotypes in the Surveillance, Epidemiology, and End Results database. Breast Cancer Res Treat. 2002 Nov;76(1):27-36. doi: 10.1023/a:1020299707510.
- Taichman LS, Van Poznak CH, Inglehart MR. Self-reported oral health and quality of life of postmenopausal breast cancer survivors on aromatase inhibitors and women without cancer diagnoses: a longitudinal analysis. Support Care Cancer. 2016 Nov;24(11):4815-24. doi: 10.1007/s00520-016-3336-6. Epub 2016 Jul 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
January 6, 2011
First Submitted That Met QC Criteria
January 6, 2011
First Posted (Estimate)
January 7, 2011
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00036200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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