Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs > 65), concurrent tamoxifen therapy (yes vs no vs unknown [e.g., on a blinded clinical study]), concurrent aromatase inhibitor therapy (yes vs no vs unknown [e.g., on a blinded clinical study]), and perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe). Patients are randomized to 1 of 4 treatment arms. The primary and secondary objectives of the study are described below.

OBJECTIVES:

Primary

• Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal dryness in patients with breast cancer.

Secondary

• Evaluate any toxicities arising from pilocarpine hydrochloride in these patients.
• Evaluate quality of life of these patients treated with pilocarpine hydrochloride.

Quality of life was assessed at baseline and then weekly for 6 weeks.

Required Characteristics:

• 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.
• 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.
• Life expectancy > 6 months
• Ability to complete questionnaire(s) by themselves or with assistance.

Contraindications:

• 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.
• Active vaginal infection
• Concurrent chemotherapy
• Acute iritis
• Current or past use of pilocarpine (regardless of purpose)
• 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.
• 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.
• Current (≤ 4weeks prior to randomization), or planned during the study period, use of any estrogen product.
• A diagnosis of asthma, COPD, CAD or narrow angle glaucoma, or known cholelithiasis.
• 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.
• Concurrent use of other anticholinergics
• Use of pharmacologic soy preparations
• Known history of cardiac arrhythmia. (Patients with occasional PVC's or PAC's that do not require treatment are eligible.)
• Prior or concurrent pelvic radiation therapy
• Prior radical pelvic surgery (TAH/BSO is allowed)
• Use of beta adrenergic antagonists
• 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