Clinical trial NCT05129332: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Dyspareunia
Keywords: Painful Intercourse
Sexual Dysfunction
Vaginal Dilator
Vaginal Moisturizer
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Difference in Mean Patient-Reported Pain Scores During Sexual Activity
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Difference in Mean Patient-Reported Pain Scores During Speculum Exam
timeFrame: Up to 16 weeks
Other outcomes:
measure: Sexual Function based on the PROMIS SexFS Score (Version 2.0)
timeFrame: Up to 16 weeks
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
state: New York
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island / Brown University
state: Rhode Island
Study officials:
affiliation: Columbia University
name: Jason D. Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: