Breast Cancer Survivors, Sexual Dysfunction
Conditions
Keywords
dyspareunia, breast cancer, sexual dysfunction, vaginal lubricant
Brief summary
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
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
Interventions
DRUGLactate-containing vaginal lubricant
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)
DRUGPlacebo vaginal lubricant
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)
Sponsors
Medical Research Collaborating Center, Seoul, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain Score of Female Sexual Function Index | Baseline and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of a Total and Other Five Domains of Female Sexual Function Index Score | Baseline and 8 weeks | 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. |
| Change of Vaginal pH | Baseline and 8 weeks | — |
| Change of Vaginal Maturation Index | Baseline and 8 weeks | 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). |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactate-containing Vaginal Lubricant apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Lactate-containing vaginal lubricant: 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) | 50 |
| Placebo apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Placebo vaginal lubricant: 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) | 57 |
| Total | 107 |
Baseline characteristics
| Characteristic | Lactate-containing Vaginal Lubricant | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 6 | 49.0 years STANDARD_DEVIATION 5.2 | 48.8 years STANDARD_DEVIATION 5.6 |
| Body mass index | 23.1 kg/m^2 STANDARD_DEVIATION 2.4 | 23.3 kg/m^2 STANDARD_DEVIATION 3.3 | 23.2 kg/m^2 STANDARD_DEVIATION 2.9 |
| Menopause No | 15 participants | 16 participants | 31 participants |
| Menopause Yes | 35 participants | 41 participants | 76 participants |
| Parity | 2 pregnancies | 2 pregnancies | 2 pregnancies |
| Sex: Female, Male Female | 50 Participants | 57 Participants | 107 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tamoxifen treatment No | 17 participants | 17 participants | 34 participants |
| Tamoxifen treatment Yes | 33 participants | 40 participants | 73 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 50 | 7 / 57 |
| serious Total, serious adverse events | 0 / 50 | 0 / 57 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactate-containing Vaginal Lubricant | Change of Pain Score of Female Sexual Function Index | 1.15 units on a scale | Standard Deviation 1.59 |
| Placebo | Change of Pain Score of Female Sexual Function Index | 1.05 units on a scale | Standard Deviation 1.54 |
Secondary
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.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lactate-containing Vaginal Lubricant | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Arousal | 0.42 units on a scale | Standard Deviation 0.72 |
| Lactate-containing Vaginal Lubricant | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Lubrication | 0.59 units on a scale | Standard Deviation 1.23 |
| Lactate-containing Vaginal Lubricant | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Orgasm | 0.38 units on a scale | Standard Deviation 0.81 |
| Lactate-containing Vaginal Lubricant | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Total | 2.85 units on a scale | Standard Deviation 4.1 |
| Lactate-containing Vaginal Lubricant | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Satisfaction | 0.11 units on a scale | Standard Deviation 0.83 |
| Lactate-containing Vaginal Lubricant | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Desire | 0.19 units on a scale | Standard Deviation 1.03 |
| Placebo | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Satisfaction | 0.43 units on a scale | Standard Deviation 1.06 |
| Placebo | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Desire | 0.45 units on a scale | Standard Deviation 0.86 |
| Placebo | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Arousal | 0.45 units on a scale | Standard Deviation 0.9 |
| Placebo | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Total | 3.81 units on a scale | Standard Deviation 5.1 |
| Placebo | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Lubrication | 0.77 units on a scale | Standard Deviation 1.5 |
| Placebo | Change of a Total and Other Five Domains of Female Sexual Function Index Score | Orgasm | 0.67 units on a scale | Standard Deviation 0.94 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactate-containing Vaginal Lubricant | Change of Vaginal Maturation Index | 4.73 vaginal maturation index | Standard Deviation 10.37 |
| Placebo | Change of Vaginal Maturation Index | 1.00 vaginal maturation index | Standard Deviation 8.5 |
Secondary
Change of Vaginal pH
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactate-containing Vaginal Lubricant | Change of Vaginal pH | -0.75 pH | Standard Deviation 0.52 |
| Placebo | Change of Vaginal pH | -0.02 pH | Standard Deviation 0.59 |