Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

NCT01693731 | Completed DMC

• 3 other identifiers: 5K23DEO217795K23DE021779HUM00048451
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Quality of Life

Keywords

Breast cancer; Periodontal Diseases; Aromatase Inhibitors; Oral Health Related Quality of Life

Outcome Measures

Primary Outcomes (1)

• Periodontal diseases

  At the time of study visit

Secondary Outcomes (2)

• Alveolar bone loss using salivary and serum-derived bone markers.

  At the time of study visit

• Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire

  At the time of study visit

Study Arms (2)

Aromatase Inhibitor

Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara

No Treatment

Healthy volunteer postmenopausal women not taking Aromatase Inhibitors

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Michigan Center For Oral Health Research (MCOHR)

Ann Arbor, Michigan, 48106, United States

Location

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.

MeSH Terms

Conditions

Periodontal Diseases; Breast Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• L. Susan Taichman, RDH MPH PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 26, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (1)