Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Linda Susan Taichman, University of Michigan
ClinicalTrials.gov Identifier:
NCT01272570
First received: January 6, 2011
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition
Breast Cancer
Xerostomia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of 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:
  • Oral health quality of life [ Time Frame: At the time of study visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole saliva


Estimated Enrollment: 58
Study Start Date: September 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aromatase Inhibitor
  • 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.
Control
• No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of thyroid or skin cancer).

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272570

Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Linda (Susan) Taichman, PhD University of Michigan
  More Information

Publications:
Responsible Party: Linda Susan Taichman, Assistant Professor of Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT01272570     History of Changes
Other Study ID Numbers: HUM00036200
Study First Received: January 6, 2011
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
breast
oral
cancer

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

ClinicalTrials.gov processed this record on April 21, 2014