Back to resultsVaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia
Primary Purpose
Dyspareunia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaginal Moisturizer
Vaginal Dilator
Sponsored by
About this trial
This is an interventional supportive care trial for Dyspareunia focused on measuring Painful Intercourse, Sexual Dysfunction, Vaginal Dilator, Vaginal Moisturizer
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older
- English or Spanish speaking
Patients currently or previously treated for:
- Gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy)
- Breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause)
- Current desire for penetrative sexual activity
Endorsement of at least one of the following in the last 6 months:
- Dyspareunia during penetrative sexual activity
- Reported sensation of penetrative object (partner's penis, sex toy) not fitting in the vagina
- Avoidance of penetrative sexual activity due to fear of pain
- Physically able to insert a vaginal dilator by themselves
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with prior primary or upfront pelvic radiation
- Patients with whole pelvic radiation at any time
- Patients with a history of chronic pelvic pain
- Patients with vulvodynia as noted on baseline pelvic exam with > 5/10 pain score during an external exam with a cotton swab
- Patients with prior vaginal dilator use for any indication
Sites / Locations
- Columbia University Irving Medical Center / NewYork-Presbyterian HospitalRecruiting
- Women & Infants Hospital of Rhode Island / Brown University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Vaginal Dilator Intervention
Control (Vaginal Moisturizer Only)
Arm Description
Patients assigned to the vaginal dilator group will be provided the device, vaginal moisturizer, an adherence calendar, and standardized verbal and written instructions from a trained health professional to apply the moisturizer and use the dilator for 15 minutes daily. Standard medical grade vaginal dilators and pure Vitamin E oil will be provided for each study participant. They have the option of purchasing a dilator and/or moisturizer of a similar nature if they choose to.
Patients assigned to vaginal moisturizer alone will receive pure Vitamin E oil and similar standardized instructions on daily use and an adherence calendar. They will apply a dime-sized amount of Vitamin E oil every day. They have the option of purchasing their own moisturizer if they choose to.
Outcomes
Primary Outcome Measures
Difference in Mean Patient-Reported Pain Scores During Sexual Activity
The difference in mean patient-reported pain scores will be calculated, during penetrative sexual activity before and after randomization to vaginal dilator use with vaginal moisturizer or vaginal moisturizer alone. Pain scores will be assessed using a 10cm vial analog scale (VAS), in which 0 indicates no pain and 10 indicates most pain (worst outcome).
Secondary Outcome Measures
Difference in Mean Patient-Reported Pain Scores During Speculum Exam
The difference in mean patient-reported pain scores will be calculated, during speculum exam before and after randomization to vaginal dilator use with vaginal moisturizer or vaginal moisturizer alone. Pain scores will be assessed using a 10cm vial analog scale (VAS), in which 0 indicates no pain and 10 indicates most pain (worst outcome).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05129332
Brief Title
Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia
Official Title
The Impact of Vaginal Dilator Therapy on Pain Scores and Sexual Function Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this randomized controlled trial, the investigators will assess the difference in mean patient-reported pain scores and sexual function between women with gynecologic or breast cancers experiencing dyspareunia (painful intercourse) who are assigned to vaginal dilator use with vaginal moisturizer (Intervention Group, n = 29) compared to vaginal moisturizer alone (Control Group, n = 29) over 16 weeks.
Detailed Description
Between 2012 and 2016, approximately 94,000 women were diagnosed with a gynecologic cancer annually and over 1.2 million women with breast cancer between 2013 and 2017. It is well known that gynecologic and breast cancers, and their treatments including surgery, adjuvant chemotherapy and endocrine therapy, and radiation, result in significant effects on the female reproductive system which can lead to sexual dysfunction. In the U.S., sexual dysfunction among gynecologic oncology patients has been reported to be as high as 90%, and over 70% among breast cancer patients. Patients who receive chemotherapy and/or endocrine therapy commonly experience dyspareunia, vaginal dryness, and challenges with desire and orgasm due to a low estrogen state. In fact, among patients with breast cancer, unaddressed sexual side effects from adjuvant endocrine therapy are one reason for early discontinuation. Hysterectomy and oophorectomy, including for ovarian cancer risk-reduction, can cause similar physical symptoms in addition to psychologic effects like anxiety related to sexual intercourse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia
Keywords
Painful Intercourse, Sexual Dysfunction, Vaginal Dilator, Vaginal Moisturizer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Dilator Intervention
Arm Type
Experimental
Arm Description
Patients assigned to the vaginal dilator group will be provided the device, vaginal moisturizer, an adherence calendar, and standardized verbal and written instructions from a trained health professional to apply the moisturizer and use the dilator for 15 minutes daily. Standard medical grade vaginal dilators and pure Vitamin E oil will be provided for each study participant. They have the option of purchasing a dilator and/or moisturizer of a similar nature if they choose to.
Arm Title
Control (Vaginal Moisturizer Only)
Arm Type
Other
Arm Description
Patients assigned to vaginal moisturizer alone will receive pure Vitamin E oil and similar standardized instructions on daily use and an adherence calendar. They will apply a dime-sized amount of Vitamin E oil every day. They have the option of purchasing their own moisturizer if they choose to.
Intervention Type
Other
Intervention Name(s)
Vaginal Moisturizer
Other Intervention Name(s)
Vitamin E Oil, Coconut Oil
Intervention Description
Natural oil-based vaginal moisturizers, like Vitamin E Oil or Coconut Oil, will be applied topically (dime-size amount) on the labia externally and vagina internally nightly, but at least 3 times per week.
Intervention Type
Device
Intervention Name(s)
Vaginal Dilator
Intervention Description
Vaginal dilator will be inserted vaginally and used daily, but at least 3 times per week.
Primary Outcome Measure Information:
Title
Difference in Mean Patient-Reported Pain Scores During Sexual Activity
Description
The difference in mean patient-reported pain scores will be calculated, during penetrative sexual activity before and after randomization to vaginal dilator use with vaginal moisturizer or vaginal moisturizer alone. Pain scores will be assessed using a 10cm vial analog scale (VAS), in which 0 indicates no pain and 10 indicates most pain (worst outcome).
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Difference in Mean Patient-Reported Pain Scores During Speculum Exam
Description
The difference in mean patient-reported pain scores will be calculated, during speculum exam before and after randomization to vaginal dilator use with vaginal moisturizer or vaginal moisturizer alone. Pain scores will be assessed using a 10cm vial analog scale (VAS), in which 0 indicates no pain and 10 indicates most pain (worst outcome).
Time Frame
Up to 16 weeks
Other Pre-specified Outcome Measures:
Title
Sexual Function based on the PROMIS SexFS Score (Version 2.0)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function (SexFS) assesses over the last 30 days interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure and is customizable so that study designers can select relevant domains and items for their study. Raw scores can range from 2 to 10 ("very" or "very much"), which is then converted to a T-score found in the appendix of the survey. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant for each domain.
Time Frame
Up to 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older
English or Spanish speaking
Patients currently or previously treated for:
Gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy)
Breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause)
Current desire for penetrative sexual activity
Endorsement of at least one of the following in the last 6 months:
Dyspareunia during penetrative sexual activity
Reported sensation of penetrative object (partner's penis, sex toy) not fitting in the vagina
Avoidance of penetrative sexual activity due to fear of pain
Physically able to insert a vaginal dilator by themselves
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients with prior primary or upfront pelvic radiation
Patients with whole pelvic radiation at any time
Patients with a history of chronic pelvic pain
Patients with vulvodynia as noted on baseline pelvic exam with > 5/10 pain score during an external exam with a cotton swab
Patients with prior vaginal dilator use for any indication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reena Vattakalam
Phone
212-342-6895
Email
rmv2110@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amita Kulkarni, MD
Email
ak4693@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason D. Wright, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amita Kulkarni, MD
Email
ak4693@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Jason D. Wright, MD
Facility Name
Women & Infants Hospital of Rhode Island / Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katina Robison, MD
Email
KRobison@wihri.org
First Name & Middle Initial & Last Name & Degree
Katina Robison, MD
12. IPD Sharing Statement
Learn more about this trial
Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia
We'll reach out to this number within 24 hrs