Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-0633 | Other Identifier | Institutional Review Board | |
| A532820 | Other Identifier | UW Madison | |
| SMPH/OBSTET & GYNEC/GYNEC ONC | Other Identifier | UW Madison | |
| NCI-2018-02729 | Registry Identifier | NCI Trial ID | |
| Protocol Version 10/3/2019 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
slow accrual as a result of COVID-19
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
Not provided
Not provided
Not provided
Breast cancer patients commonly take medications to reduce the risk of recurrence, including aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient adherence. Early discontinuation of AI therapy results in an increased risk of cancer recurrence and increased risk of breast cancer-related death. Common side effects include vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP) aimed at stimulating nitric oxide production to consequently increase vaginal lubrication, and improve the symptoms of vulvovaginal atrophy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRP Therapy | Experimental | All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Renewal Program | Device | Therapeutic vibrating wand. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Superficial Vaginal Cells | The investigators expect the percentage of superficial vaginal cells to be greater at the post-intervention time point when compared to the pre-intervention time point. If the percentage of superficial vaginal cells is ≥ 4% following the intervention, then the response will be considered positive. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vaginal pH | Changes in the vaginal pH will be analyzed to determine the extent to which the changes correlate with changes in the primary outcome and with patient reported outcomes. Given the longitudinal nature of the study, linear and generalized linear mixed effects models will be fit to the data gathered. The restricted maximum likelihood (REML) criterion will be used and 95% semi-parametrically bootstrapped confidence intervals will be obtained for all parameters. All statistical analyses will be conducted using R (R Core Team 2014). |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to AI Therapy | Adherence to AI therapy will be determined using patient-reported logs. | up to 12 weeks |
Inclusion Criteria:
Have completed active primary treatment
Have been receiving AIs for at least 6 months prior to enrollment
Plan to continue AIs for an additional 3 months
Amenorrhea for at least 12 months at enrollment
Participants must be able to read and write in English
Participants must have < 2% superficial vaginal cells on cytologic evaluation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Spencer | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
Not provided
| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were recruited with the help of the University of Wisconsin Carbone Cancer Center in November and December 2019. Recruitment was suspended in March 2020 due to the COVID-19 pandemic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VRP Therapy | All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VRP Therapy | All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Superficial Vaginal Cells | The investigators expect the percentage of superficial vaginal cells to be greater at the post-intervention time point when compared to the pre-intervention time point. If the percentage of superficial vaginal cells is ≥ 4% following the intervention, then the response will be considered positive. | End of study samples unavailable, decision was made not to analyze primary outcome as it was not powered to produce meaningful results. | Posted | up to 12 weeks |
|
up to 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VRP Therapy | All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time. Vaginal Renewal Program: Therapeutic vibrating wand. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation | Reproductive system and breast disorders | CTCAE V.4 | Systematic Assessment |
This study was terminated early with 2 participants due to the COVID-19 pandemic. It is not powered for meaningful results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Spencer, MD, MS | University of Wisconsin Carbone Cancer Center | 608-265-1700 | rjspencer2@wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2019 | May 24, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
Prospective Simon two-stage study design
Not provided
Not provided
Not provided
Not provided
| up to 12 weeks |
| Patient Reported Outcomes: Number of Subjects With Improved Anxiety | Number of subjects with improved anxiety outcomes per over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Anxiety scale measures patient perceived changes in anxiety and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome. | up to 12 weeks |
| Patient Reported Outcomes: Number of Subjects With Improved Depression | Number of subjects with improved depression outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Depression scale measures patient perceived changes in depression and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome. | up to 12 weeks |
| Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes | Number of subjects with improved sexual function outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Sexual Function Profile scale measures patient perceived changes in sexual function and includes 10 questions that they answer about their functional state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics. | up to 12 weeks |
| Patient Reported Outcomes: Number of Subjects With Improved Global Health | Number of subjects with improved global health over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Health scale measures patient perceived changes in health and includes 10 questions that they answer about their perceived health in the past 7 days. Higher scores indicate a higher perceived level of overall health. | up to 12 weeks |
| Patient Reported Outcomes: Number of Subjects With Improved Sex Life | Number of subjects with improved sex life over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Satisfaction with Sex Life scale measures patient perceived changes in the satisfaction of their sex life and includes 7 questions that they answer about their perceived state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics. | up to 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Change in Vaginal pH | Changes in the vaginal pH will be analyzed to determine the extent to which the changes correlate with changes in the primary outcome and with patient reported outcomes. Given the longitudinal nature of the study, linear and generalized linear mixed effects models will be fit to the data gathered. The restricted maximum likelihood (REML) criterion will be used and 95% semi-parametrically bootstrapped confidence intervals will be obtained for all parameters. All statistical analyses will be conducted using R (R Core Team 2014). | No data to analyze. | Posted | up to 12 weeks |
|
|
| Secondary | Patient Reported Outcomes: Number of Subjects With Improved Anxiety | Number of subjects with improved anxiety outcomes per over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Anxiety scale measures patient perceived changes in anxiety and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Secondary | Patient Reported Outcomes: Number of Subjects With Improved Depression | Number of subjects with improved depression outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Depression scale measures patient perceived changes in depression and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome. | only 1 participant completed this survey | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Secondary | Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes | Number of subjects with improved sexual function outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Sexual Function Profile scale measures patient perceived changes in sexual function and includes 10 questions that they answer about their functional state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics. | Incomplete data, unable to evaluate. | Posted | up to 12 weeks |
|
|
| Secondary | Patient Reported Outcomes: Number of Subjects With Improved Global Health | Number of subjects with improved global health over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Health scale measures patient perceived changes in health and includes 10 questions that they answer about their perceived health in the past 7 days. Higher scores indicate a higher perceived level of overall health. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Secondary | Patient Reported Outcomes: Number of Subjects With Improved Sex Life | Number of subjects with improved sex life over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Satisfaction with Sex Life scale measures patient perceived changes in the satisfaction of their sex life and includes 7 questions that they answer about their perceived state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics. | Incomplete data, unable to evaluate. | Posted | up to 12 weeks |
|
|
| Other Pre-specified | Adherence to AI Therapy | Adherence to AI therapy will be determined using patient-reported logs. | No data to analyze | Posted | up to 12 weeks |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| Vulvar Stinging | Reproductive system and breast disorders | CTCAE V.4 | Systematic Assessment |
|
| Perineal Chaffing | Reproductive system and breast disorders | CTCAE V.4 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001519 | Behavior |