Therapy to Prevent Sexual Pain in Breast Cancer Survivors

Study Overview
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Brief Summary
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The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.

Detailed Description
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For this study there will be three visits over a 3 month period. Subjects will undergo a gynecological exam at the screening visit to determine the severity of pain associated with uncomfortable intercourse. A touch test using Q-tips will be used during screening exam so subjects can report pain during application of both study drug and placebo. Subjects will also report pain during tampon test. A sample of vaginal cells and liquid will be obtained at screening visit so that PI can rule out possible infection, disease, or disorders. PI will also show subject the area of the vestibule in a mirror so that subject can apply study drug at home properly. Subjects will fill out 4 questionnaires about medical and health history, cancer history, pain, and distress and sexual activity. Subject will be given a supply of either study drug or placebo to take home. The first visit will last approximately 2 hours. Subjects will return for a second visit after 4 weeks and a third visit after 8 weeks for diary review, questionnaires, and examination. The second and third visit examinations will be repeats of the examination done at the first visit, but there will be no comparison with placebo, the PI will use only study drug during the touch test. The second and third visits will last approximately 1 hour. Subjects will fill out questionnaires throughout study participation. Topics include; medical and health history, cancer history, pain, distress and sexual activity. Subjects will also fill out a diary that charts tampon test completed from home, sexual activity performed, pain levels and study drug application days.

Official Title
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Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer

Conditions
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Vulvodynia, Dyspareunia, Breast Cancer, Menopause

Intervention / Treatment
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* Drug: Topical liquid lidocaine
* Drug: Topical saline


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria Women aged 18 to 70 years old. Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive). 1 year from diagnosis of breast cancer. Stable heterosexual partnership =/>5 years or by investigator discretion. More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain). Menopausal, demonstrated by at least one of the following: i. cessation of menses for 1 years ii. Bilateral oophorectomy iii. Follicle Stimulating Hormone (FSH) level >25 in women below age 50 with an ovary and scarred or absent uterus (acceptable FSH levels can be inferred if the woman's oncologist monitors FSH during aromatase inhibitor therapy). Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine. Willingness to evaluate the liquids by use of a tampon test as many as 4 times per month, and willingness to attempt intercourse if the tampon test indicates tolerable penetrative pain. 3.2 Exclusion Criteria Diagnosis of benign or malignant phyllodes tumor of the breast. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia). Has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam). Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent. The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study. Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia). Potential subject has used topical or systemic estrogen within the last 4 months. Has continued tenderness of vestibule mucosa immediately after application of both test liquids. Allergy to lidocaine or other numbing agents.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical liquid lidocaine<br> | Drug: Topical liquid lidocaine<br>* active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule<br>Drug: Topical saline<br>* saline applied to the vestibule mucosa will not reverse the local tenderness<br>* Other names: water;|
| Placebo Comparator: Topical Saline<br> | Drug: Topical liquid lidocaine<br>* active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule<br>Drug: Topical saline<br>* saline applied to the vestibule mucosa will not reverse the local tenderness<br>* Other names: water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Entry Dyspareunia With Non-hormonal Therapy | Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being no pain and 10 being worst possible pain). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase. | During Phase II (0-4 weeks) and during Phase III (5-12 weeks) | 
| Location of Pain in Postmenopausal Dyspareunia | To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0=no pain and 10=the worst pain you have ever felt. | Enrollment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Quality of Sexual Life - Visit 1 | To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function). | Visit 1 (Enrollment) | 
| Improvement of Quality of Sexual Life - Visit 2 | To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function). | Visit 2 (Week 4) | 
| Improvement of Quality of Sexual Life - Visit 3 | To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function). | Visit 3 (End of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvodynia, Dyspareunia, Breast Cancer, Menopause, Vaginal dryness, Painful intercourse