Phase II Study of the Effect of the Topical Corticosteroid Fluocinonide in Patients on Endocrine Therapy for Either Breast Cancer or an Increased Risk for Breast Cancer With Symptoms of Vaginal Dryness and Dyspareunia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Symptom Scores of Vaginal Dryness
研究概览
简要总结
This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
SECONDARY OBJECTIVES:
I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention
- •Vaginal dryness or dyspareunia must be present for at least two months prior to study entry
- •Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study
- •Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream
- •Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance
- •Subjects must sign informed consent
- •Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent
排除标准
- •Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)
- •Use of any estrogen containing medications, products, or preparations
- •Use of any systemic oral or parenteral steroid containing medications is not permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted
- •Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia
- •Subject reported symptoms of vaginal infection with significant vaginal discharge or odor
- •Known current vaginal infection
- •Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms
- •Known intolerance of topical steroid preparations
- •Pregnant or lactating women (to be obtained via subject report only)
- •Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or Cushing's syndrome
- •No prior chemotherapeutic treatment for any malignancy other than breast cancer
研究组 & 干预措施
Supportive care (fluocinonide cream)
Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
干预措施: Fluocinonide Cream (Drug)
Supportive care (fluocinonide cream)
Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
干预措施: Management of Therapy Complications (Procedure)
Supportive care (fluocinonide cream)
Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in Symptom Scores of Vaginal Dryness
时间窗: Baseline and 4 weeks
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
Change in Symptom Scores of Dyspareunia
时间窗: Baseline and 4 weeks
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
次要结局
- Change in Total Vaginal Index Score.(Baseline and 4 weeks)
- Change in Vaginal Itching Symptom Scores by Age Characteristics(Baseline and 4 weeks)
- Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics(Baseline and 4 weeks)
- Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics(Baseline and 4 weeks)
- Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics(Baseline and 4 weeks)
- Number of Patients Experiencing Toxicities(Over 4 weeks)
- Change in Vaginal Dryness Symptom Scores by Age Characteristics(Baseline and 4 weeks)
- Change in Dyspareunia Symptom Scores by Age Characteristics(Baseline and 4 weeks)
- Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics(Baseline and 4 weeks)
- Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics(Baseline and 4 weeks)
- Change in Symptom Scores of Vaginal Itching(Baseline and 4 weeks)
- Change in Dyspareunia Symptom Scores by Menopause Status Characteristics(Baseline and 4 weeks)
- Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics(Baseline and 4 weeks)
- Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics(Baseline and 4 weeks)
- Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics(Baseline and 4 weeks)
- Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics(Baseline and 4 weeks)
- Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics(Baseline and 4 weeks)
- Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics(Baseline and 4 weeks)
- Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics(Baseline and 4 weeks)
- Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics(Baseline and 4 weeks)
- Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics(Baseline and 4 weeks)
- Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics(Baseline and 4 weeks)
- Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics(Baseline and 4 weeks)
- Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics(Baseline and 4 weeks)
研究者
Kathleen Kemmer
Principal Investigator
OHSU Knight Cancer Institute