Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia

Columbia University

Status: Withdrawn

Conditions: Dyspareunia

Treatments: Device: Vaginal Dilator; Other: Vaginal Moisturizer

Study type: Interventional

Funder types: Other

Identifiers

NCT05129332

AAAT8915

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Vaginal Dilator Intervention

Experimental group

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.

Treatment:

Other: Vaginal Moisturizer

Device: Vaginal Dilator

Control (Vaginal Moisturizer Only)

Other group

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.

Treatment:

Other: Vaginal Moisturizer