Columbia University
Jason D. Wright
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.
Dyspareunia
Vaginal Moisturizer
Vaginal Dilator
Not Applicable
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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 0 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Supportive Care |
| 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 |
| Actual Study Start Date : | August 3, 2022 |
| Estimated Primary Completion Date : | February 7, 2024 |
| Estimated Study Completion Date : | February 7, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Vaginal Dilator Intervention 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. |
Other: Vaginal Moisturizer |
|
Other: Control (Vaginal Moisturizer Only) 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. |
Device: Vaginal Dilator |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Not yet recruiting
Women & Infants Hospital of Rhode Island / Brown University
Providence, Rhode Island, United States, 02905