TriangleNCT01422408 · REGISTRY CONDITION SEARCH
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-08-09
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Change in Symptom Scores of Vaginal Dryness
Change in Symptom Scores of Dyspareunia
Change in Symptom Scores of Vaginal Itching
Change in Total Vaginal Index Score.
Number of Patients Experiencing Toxicities
Change in Vaginal Dryness Symptom Scores by Age Characteristics
Change in Dyspareunia Symptom Scores by Age Characteristics
Change in Vaginal Itching Symptom Scores by Age Characteristics
Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics
Change in Dyspareunia Symptom Scores by Menopause Status Characteristics
Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics
Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics
Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics
Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics
Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics
Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics
Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics
Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics
Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics
Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics
Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics
Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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 Exclusion Criteria: * 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
- intervention Names
- Drug: Fluocinonide Cream
- Procedure: Management of Therapy Complications
- Other: Questionnaire Administration
- label
- Supportive care (fluocinonide cream)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Supportive care (fluocinonide cream)
- description
- Given topically
- name
- Fluocinonide Cream
- other Names
- fluocinonide
- Lidex
- Vanos
- type
- DRUG
- arm Group Labels
- Supportive care (fluocinonide cream)
- description
- Receive fluocinonide cream
- name
- Management of Therapy Complications
- other Names
- complications of therapy, management of
- type
- PROCEDURE
- arm Group Labels
- Supportive care (fluocinonide cream)
- description
- Ancillary studies
- name
- Questionnaire Administration
- type
- OTHER
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- SUPPORTIVE_CARE
Enrollment
- count
- 34
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Change in Symptom Scores of Vaginal Dryness
- time Frame
- Baseline and 4 weeks
- description
- 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.
- measure
- Change in Symptom Scores of Dyspareunia
- time Frame
- Baseline and 4 weeks
- secondary Outcomes
- description
- 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-secondary 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.
- measure
- Change in Symptom Scores of Vaginal Itching
- time Frame
- Baseline and 4 weeks
- description
- Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. 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 -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
- measure
- Change in Total Vaginal Index Score.
- time Frame
- Baseline and 4 weeks
- description
- Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.
- measure
- Number of Patients Experiencing Toxicities
- time Frame
- Over 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Dryness and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Vaginal Dryness Symptom Scores by Age Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Dyspareunia Symptom Scores by Age Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Itching and Age) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Vaginal Itching Symptom Scores by Age Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Dyspareunia Symptom Scores by Menopause Status Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Itching and Menopause status) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
- time Frame
- Baseline and 4 weeks
- description
- Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.
- measure
- Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics
- time Frame
- Baseline and 4 weeks
Full study description
- brief Summary
- 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.
- detailed Description
- 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. III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream. IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream. OUTLINE: Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice