Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer
Condition: Breast Cancer; Vaginal Dryness
MeSH terms: Breast Neoplasms
Intervention: pilocarpine hydrochloride; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 201.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sexuality and reproductive issues; sexual dysfunction; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Summary:

      RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients
      with breast cancer It is not yet known whether pilocarpine is more effective than a placebo
      in treating vaginal dryness in patients with breast cancer.

      PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works
      compared to a placebo in treating vaginal dryness in patients with breast cancer.
    

Eligibility criteria:

        Required Characteristics:

          1. Adult post menopausal women or women with no childbearing potential (≥ 18 years) with
             a history of breast cancer (currently no evidence of disease) or women who do not want
             to take vaginal estrogen for a fear of an increased risk of breast cancer.
             Postmenopausal status will be determined by the primary physician.

          2. Significant vaginal complaints defined as persistent vaginal dryness and/or itching of
             sufficient severity to make a patient desire therapeutic intervention. Symptoms should
             have been present ≥ 2 months prior to randomization.

          3. Life expectancy > 6 months

          4. Ability to complete questionnaire(s) by themselves or with assistance.

        Contraindications:

          1. Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤2 months prior to
             randomization or plans to initiate or discontinue any of these medications during the
             6-week study.

          2. Active vaginal infection

          3. Concurrent chemotherapy

          4. Acute iritis

          5. Current or past use of pilocarpine (regardless of purpose)

          6. Planned use of any vaginal preparations during the study period (including any over
             the counter or herbal preparations). Note: Lubricants used during sexual intercourse
             are permitted.

          7. Use of any vaginal preparations ≤ 1 week prior to study entry (Exception: If patient
             has used vaginal preparations during the previous week but will stop, then they can be
             placed on study with plans to start with pretreatment questionnaire one week later).
             Note: Lubricants used during sexual intercourse are permitted.

          8. Current (≤ 4weeks prior to randomization), or planned during the study period, use of
             any estrogen product.

          9. A diagnosis of asthma, COPD, CAD or narrow angle glaucoma, or known cholelithiasis.

         10. Hepatic or renal insufficiency defined as a history of an elevation of SGOT ≥1.5 x ULN
             or creatinine ≥ 1.5 x ULN within the past year.

         11. Concurrent use of other anticholinergics

         12. Use of pharmacologic soy preparations

         13. Known history of cardiac arrhythmia. (Patients with occasional PVC's or PAC's that do
             not require treatment are eligible.)

         14. Prior or concurrent pelvic radiation therapy

         15. Prior radical pelvic surgery (TAH/BSO is allowed)

         16. Use of beta adrenergic antagonists

         17. Diagnosis of any of the following conditions:

               -  Vulvar and vaginal dysplasia

               -  Essential vulvodynia

               -  Vulvar vestibulitis

               -  Vaginal prolapse

               -  Bartholin cyst/abscess

               -  History of Bartholin gland surgery

               -  Lichen sclerosis

               -  Lichen planus of the vulvovaginal region

               -  Desquamative vaginitis