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Trial record 9 of 49 for:    gum disease | NIH

Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01693731
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Linda Susan Taichman, University of Michigan

Tracking Information
First Submitted Date September 18, 2012
First Posted Date September 26, 2012
Last Update Posted Date May 20, 2015
Study Start Date April 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2012)
Periodontal diseases [ Time Frame: At the time of study visit ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01693731 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 24, 2012)
  • Alveolar bone loss using salivary and serum-derived bone markers. [ Time Frame: At the time of study visit ]
  • Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire [ Time Frame: At the time of study visit ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Official Title Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
Brief Summary 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.
Detailed Description

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.
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Non-Probability Sample
Study Population This study will have a sample of 300 postmenopausal women; 150 healthy women and 150 with early breast cancer using Aromatase Inhibitors
Condition
  • Periodontal Disease
  • Quality of Life
Intervention Not Provided
Study Groups/Cohorts
  • Aromatase Inhibitor
    Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
  • No Treatment
    Healthy volunteer postmenopausal women not taking Aromatase Inhibitors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 24, 2012)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
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, 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.)
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01693731
Other Study ID Numbers 5K23DEO21779
5K23DE021779 ( U.S. NIH Grant/Contract )
HUM00048451 ( Other Identifier: UM MEDIRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Linda Susan Taichman, University of Michigan
Study Sponsor University of Michigan
Collaborators National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: L. Susan Taichman, RDH MPH PhD University of Michigan
PRS Account University of Michigan
Verification Date May 2015