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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial

Conditions
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Sexual Dysfunction, Breast Cancer Survivors

Intervention / Treatment
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* Drug: Lactate-containing vaginal lubricant
* Drug: Placebo vaginal lubricant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactate-containing Vaginal Lubricant<br>apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) | Drug: Lactate-containing vaginal lubricant<br>* 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)<br>* Other names: Clino-san(commercial name in Korea);|
| Placebo Comparator: Placebo<br>apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) | Drug: Placebo vaginal lubricant<br>* 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)<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | 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. | Baseline and 8 weeks | 
| Change of Vaginal pH |  | 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). | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyspareunia, breast cancer, sexual dysfunction, vaginal lubricant