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Trial record 15 of 121 for:    Open Studies | "Periodontal Diseases"

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
  Purpose

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.


Condition
Periodontal Disease
Quality of Life

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Periodontal diseases [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aromatase Inhibitor
Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
No Treatment
Healthy volunteer postmenopausal women not taking 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.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693731

Contacts
Contact: Tina Lucas, BA 734-998-0047 tllucas@umich.edu
Contact: Susan Taichman, RDH MPH PhD 734-764-5502

Locations
United States, Michigan
Michigan Center For Oral Health Research (MCOHR) Recruiting
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: L. Susan Taichman, RDH MPH PhD University of Michigan
  More Information

No publications provided

Responsible Party: Linda Susan Taichman, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01693731     History of Changes
Other Study ID Numbers: 5K23DEO21779, 5K23DE021779, HUM00048451
Study First Received: September 18, 2012
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Breast cancer
Periodontal Diseases
Aromatase Inhibitors
Oral Health Related Quality of Life

Additional relevant MeSH terms:
Periodontal Diseases
Breast Neoplasms
Breast Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Stomatognathic Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014