BACKGROUND: Problems related to sexual function are known to affect quality of life in female breast cancer survivors (BCS). A leading symptom of sexual dysfunction reported by BCS is dyspareunia, defined as moderate to severe penetrative pain with intercourse that results in reduced frequency of intercourse or abstinence. Dyspareunia in females is most commonly caused by vaginal dryness and primarily treated with estrogen therapy, a contraindication for many BCS. A recent trial found that estrogen-deficient BCS with dyspareunia who applied topical lidocaine to the vulvar vestibule (VV) prior to penetrative intercourse (PI) reported decreased pain during PI and improvement of sexual distress (Goetsch MF, JCO 2015). Identification of additional non-hormonal therapies to target the VV prior to PI may therefore provide treatment options for the improvement of sexual dysfunction in BCS with dyspareunia.
TRIAL DESIGN: This is a double-blind, randomized trial to evaluate the benefits of applying natural lubricant MoistHer (MH) to the VV prior to PI in female BCS with dyspareunia. Subjects must be female ≥18 years BCS without active treatment (except for hormonotherapy), in a stable heterosexual partnership for ≥5 years, and report ≥ 3 months of consistent pain with PI. Patients with a history of pelvic pain, pelvic floor myalgia, vulvar dermatoses, or vaginismus will be excluded. Subjects will be randomized 1:1 to blinded home therapies of either MH or Topical Lidocaine (TL) for application to VV. MH is a commercially available vaginal moisturizer made of emu oil, tocopherol, safflower oil, and aloe extract and will be supplied by manufacturer Dromeo Inc. TL will be a 4% aqueous lidocaine hydrochloride solution prepared by research pharmacist (RP). Both MH and TL will be dispensed by RP in identical unmarked bottles. Subjects will agree to apply study liquid to VV and attempt PI at least twice per week for 4 weeks while maintaining a study diary to record pain scores. Outcomes will be measured via Sexual Function Questionnaire (SFQ), Female Sexual Distress Score-Revised (FSDS-R), and a rating of pain during PI on a scale of zero (no pain) to 10 (worst pain) via Numerical Rating Scale (NRS), to be completed by subjects at baseline, 2 weeks, and 4 weeks.
AIMS: Primary endpoint is pain with PI, to be reported as a score on the NRS. Secondary endpoints are improved quality of sexual life and resumption of PI, to be measured by the SFQ and FSDS-R.
STATS/TARGET ACCRUAL: A total of 50 patients will be recruited and randomized to receive either MH or TL at a 1:1 ratio (25 per group) using the Pocock-Simon dynamic allocation method. This sample size will achieve 94% power to detect at least 1.5 points NRS mean difference between treatments. NRS change will be compared between the two arms using a two-sample t-test (Pooled Standard error or Satterthwaite approximation as appropriate). Secondary outcomes include the SFQ and FSDS-R for which a longitudinal analysis of subscale scores will be conducted using a generalized linear mixed-effects model with fixed effects for treatment group and time. All statistical analyses will be conducted using SAS 9.3 [SAS Institute Inc., Cary, NC, USA]. Statistical significance will be defined as p < 0.05.
Citation Format: Bendinger GM, Baptist S, Alvarez Tapias C, McGuire E, Rados K, Nixon D, Randolph K, McNight JE, Pabbathi H, Panicker R, Johnson AT, Geisler JP, Manahan KJ, Lammersfeld C, Avarez RH. A randomized study comparing MoistHer to topical lidocaine for female breast cancer survivors with dyspareunia [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-07-04.