Status:
COMPLETED
Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Vaginal Dryness
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 vagi...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00343382
Start Date
December 1 2006
End Date
December 1 2012
Last Update
August 12 2016
Active Locations (192)
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1
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
2
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
3
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
4
St. Anthony Central Hospital
Denver, Colorado, United States, 80204