This phase III trial tests whether using vaginal dilators will decrease pain with sexual intercourse (dyspareunia) and improve sexual health in women with gynecologic or breast cancers without prior pelvic radiation treatment. Vaginal dilators are tube-shaped devices that are used to stretch the vagina. The vagina can become drier, less elastic (stretchy), narrower, and shorter with cancer treatments or surgery to lower risk of cancer, or menopause. Starting vaginal dilator therapy may help with these changes. This study may help determine if vaginal dilators will decrease pain with sexual intercourse and improve patients’ sexual health.
Additional locations may be listed on ClinicalTrials.gov for NCT05129332.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the feasibility of vaginal dilator therapy over 16 weeks based on the percentage of patients with gynecologic or breast cancers reporting dyspareunia who complete the 16-week assessment.
SECONDARY OBJECTIVES:
I. To assess the efficacy of vaginal dilator therapy by comparing the change in patient reported pain scores during penetrative sexual activity at the beginning and end of the 16-week study period.
II. To assess the efficacy of vaginal dilator therapy by comparing the change in pain scores during speculum exam at the beginning and end of the 16-week study period.
III. To evaluate the improvement of sexual function of patients with gynecologic or breast cancers reporting dyspareunia before and after the 16 week study period, based on responses from the sexual function questionnaire with Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function Measures, Female Sexual Function Index (FSFI), and Sexually Satisfying Events.
OUTLINE:
Patients undergo vaginal dilator therapy with vaginal moisturizer (Replens) for 15 minutes daily, but at least 3 times per week, for 16 weeks. Patients also undergo pelvic examination at baseline and at 16 weeks.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorJason D. Wright
