Clinical trial NCT01272570: Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors
Official title: Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Xerostomia
Keywords: breast
oral
cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 58
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 criteria: 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.)

Primary outcomes:
measure: Periodontal diseases
timeFrame: At the time of study visit
Secondary outcomes:
measure: Oral health quality of life
timeFrame: At the time of study visit
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: Linda (Susan) Taichman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sonis ST, Fey EG. Oral complications of cancer therapy. Oncology (Williston Park). 2002 May;16(5):680-6; discussion 686, 691-2, 695.
citation: 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.
citation: 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.
citation: 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.
citation: 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.