Oxybutynin Chloride in Managing Hot Flashes
Condition: Breast Carcinoma; Ductal Breast Carcinoma In Situ; Hot Flashes; Lobular Breast Carcinoma In Situ; No Evidence of Disease
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Hot Flashes
Intervention: Oxybutynin Chloride; Placebo; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given PO; Given PO; Ancillary studies; Ancillary studies
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well oxybutynin chloride works in managing hot
      flashes in patients who are not candidates for, or not interested in hormone replacement
      therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes,
      however doses used in prior studies have resulted in side effects. This trial is evaluating
      lower doses of oxybutynin with the goal of determining if they are efficacious with less side
      effects.

      ADAM-VTE
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular carcinoma
             in situ (LCIS) (currently without evidence of malignant disease) OR a concern about
             taking estrogen for fear of breast cancer

          -  Bothersome hot flashes (defined by their occurrence of >= 28 times per week and of
             sufficient severity to prompt the patient to seek therapeutic intervention)

          -  Presence of hot flashes for > 30 days prior to study entry

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1

          -  Ability to provide informed written consent

          -  Life expectancy >= 6 months

          -  Willing to work with the enrolling institution for follow-up (during the active
             monitoring phase of the study)

        Exclusion Criteria:

          -  Any of the following current (=< 4 weeks prior) or planned therapies:

               -  Antineoplastic chemotherapy (anti-HER2 agents allowed)

               -  Androgens

               -  Estrogens (any delivery route)

               -  Progestogens

               -  Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have
                  been on a constant dose for at least 28 days and must not be expected to stop the
                  medication during the study period

               -  Selective serotonin reuptake inhibitors (SSRIs)/serotonin?norepinephrine reuptake
                  inhibitors (SNRIs), when being used for hot flash management or other indications
                  such as depression, is allowed, assuming the dose will remain unchanged for the
                  study duration

               -  Gabapentin/pregabalin, when being used for hot flash management (use for other
                  indications, such as pain, is allowed, assuming the dose will remain unchanged
                  for the study duration)

               -  Clonidine

               -  Agents with known potent anticholinergic activity; agents with mild-moderate
                  anticholinergic activity are allowed

          -  Prior use of oxybutynin during the period in which patient has had hot flashes

          -  Pregnant women

          -  Nursing women

          -  History of any of the following contraindications to oxybutynin:

               -  Uncontrolled gastroesophageal reflux disease (GERD) despite appropriate therapy;
                  if patient has history of GERD, but symptoms are well-controlled with medical
                  treatment, patient is eligible

               -  Ulcerative colitis

               -  Narrow-angle glaucoma

               -  Urinary retention

               -  Hypersensitivity to oxybutynin or any other components of the product

               -  Current uncontrolled hyperthyroidism

               -  Coronary heart disease (angina or prior myocardial infarction)

               -  Congestive heart failure

               -  Symptomatic cardiac arrhythmias

               -  Current uncontrolled hypertension

               -  Myasthenia gravis

               -  Dementia