NCT01693731已完成不适用
Oral Health in Breast Cancer Survivors on Aromatase Inhibitors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Periodontal diseases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
- •No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of localized thyroid or skin cancer).
排除标准
- •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.)
结局指标
主要结局
Periodontal diseases
时间窗: At the time of study visit
次要结局
- 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)
研究者
Linda Susan Taichman
Principal Investigator
University of Michigan
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated PainBreast CancerNCT01028352University of Michigan Rogel Cancer Center35
Unknown
3 期
Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast CancerNeoadjuvant TherapyNCT02769104Zhejiang Cancer Hospital120
已完成
不适用
Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated PatientsBreast CancerNCT01983995University of Michigan49
终止
2 期
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer PatientsSleep Initiation and Maintenance DisordersPainNCT01921296Lynn Henry2
已完成
不适用
Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer PatientsBreast CancerNCT01051609Jonsson Comprehensive Cancer Center27