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Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linda Susan Taichman, University of Michigan
ClinicalTrials.gov Identifier:
NCT01693731
First received: September 18, 2012
Last updated: February 18, 2014
Last verified: February 2014

September 18, 2012
February 18, 2014
April 2012
June 2015   (final data collection date for primary outcome measure)
Periodontal diseases [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01693731 on ClinicalTrials.gov Archive Site
  • Alveolar bone loss using salivary and serum-derived bone markers. [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
  • Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

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.

OBJECTIVES:

Primary

This cross-sectional prevalence study seeks to investigate the incidence and severity of oral health changes, specifically of periodontal conditions, among breast cancer survivors and the ways in which these outcomes affect their quality of life.

Secondary

  • To determine the prevalence and severity of oral conditions in postmenopausal women with early stage breast cancer using adjuvant AI therapy as compared to postmenopausal women not using adjuvant AI therapy.
  • To determine if adjuvant AI therapy use is associated with greater alveolar bone loss or increased levels of bone turnover biomarkers in postmenopausal women with cancer undergoing adjuvant AI therapy compared to postmenopausal women not receiving AI therapy.
  • To determine the oral health-related quality of life among postmenopausal women with early stage breast cancer who are receiving adjuvant AI therapy.
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Each patient will have 5ml of blood collected at the visit. Saliva, and urine will also be collected at the study visit.

Non-Probability Sample

This study will have a sample of 300 postmenopausal women; 150 healthy women and 150 with early breast cancer using Aromatase Inhibitors

  • Periodontal Disease
  • Quality of Life
Not Provided
  • Aromatase Inhibitor
    Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
  • No Treatment
    Healthy volunteer postmenopausal women not taking Aromatase Inhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2015
June 2015   (final data collection date for primary outcome measure)

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.)
Female
Not Provided
Yes
Contact: Tina Lucas, BA 734-998-0047 tllucas@umich.edu
Contact: Susan Taichman, RDH MPH PhD 734-764-5502
United States
 
NCT01693731
5K23DEO21779, 5K23DE021779, HUM00048451
Yes
Linda Susan Taichman, University of Michigan
University of Michigan
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: L. Susan Taichman, RDH MPH PhD University of Michigan
University of Michigan
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP