Therapy to Prevent Sexual Pain in Breast Cancer Survivors
Condition: Vulvodynia; Dyspareunia; Breast Cancer; Menopause
MeSH terms: Breast Neoplasms; Dyspareunia; Vulvodynia
Intervention: Topical liquid lidocaine; Topical saline
Intervention description: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule; saline applied to the vestibule mucosa will not reverse the local tenderness
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Vulvodynia; Dyspareunia; Breast Cancer; Menopause; Vaginal dryness; Painful intercourse

Summary:

      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.
    

Eligibility criteria:

        Eligibility Criteria

          1. Women aged 18 to 70 years old.

          2. Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).

          3. 1 year from diagnosis of breast cancer.

          4. Stable heterosexual partnership =/>5 years or by investigator discretion.

          5. More than 6 months of consistent insertional pain with intercourse (may have stopped
             having intercourse due to this consistent experience of pain).

          6. 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).

          7. Willingness to enter a study comparing a topical placebo liquid to topical liquid
             lidocaine.

          8. 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

          1. Diagnosis of benign or malignant phyllodes tumor of the breast.

          2. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep
             dyspareunia).

          3. 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).

          4. Partner has a problem of sexual dysfunction limiting his performance or making it
             inconsistent.

          5. The potential subject or her partner has a serious current medical condition that
             might interrupt completion of a 6 month study.

          6. Potential subject has been diagnosed by a physical therapist with significant pelvic
             floor muscle dysfunction causing pain (pelvic floor myalgia).

          7. Potential subject has used topical or systemic estrogen within the last 4 months.

          8. Has continued tenderness of vestibule mucosa immediately after application of both
             test liquids.

          9. Allergy to lidocaine or other numbing agents.