Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors

Seoul National University Hospital136 enrolled

Overview

The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.

Study scheme * study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks * control arm: placebo apply Outcome measures * Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk * vaginal maturation index: at 0 wk and 8 wk * vaginal pH: at 0 wk and 8 wk

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Sexual Dysfunction Breast Cancer Survivors

Interventions

Lactate-containing vaginal lubricantDRUG

vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Placebo vaginal lubricantDRUG

vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * breast cancer survivors over 20 years-old * premenopausal at the time of diagnosis * treated with operation and chemotherapy * newly developed dyspareunia after cancer treatment Exclusion Criteria: * recent (\< 2 months) start or cessation of hormonal treatment (tamoxifen etc.) * depression or other psychological problems * active vaginal infection * evidence of cancer recurrence * previously use of lactate-containing lubricants * other chronic diseases which severely disturb the sexual life

Locations (1)

Myung Jae, Jeon

Seoul, South Korea

Outcomes

Primary Outcomes

Change of Pain Score of Female Sexual Function Index

The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.

Time frame: Baseline and 8 weeks

Secondary Outcomes

Change of a Total and Other Five Domains of Female Sexual Function Index Score

Time frame: Baseline and 8 weeks

Change of Vaginal pH

Time frame: Baseline and 8 weeks

Change of Vaginal Maturation Index

Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).

Time frame: Baseline and 8 weeks

Data from ClinicalTrials.gov

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