Breast Carcinoma Clinical Trial
Official title:
A Phase III, Double-Blind, Controlled Trial of Oxybutynin in the Management of Hot Flashes
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
PRIMARY OBJECTIVES:
I. To determine whether oxybutynin chloride (oxybutynin) can diminish hot-flash activity in
women with a history of breast cancer or in women who have a concern about taking estrogen
for fear of breast cancer.
SECONDARY OBJECTIVES:
I. To perform a dose-response evaluation of two oxybutynin doses. II. To determine the
toxicity of oxybutynin in the study population. III. To assess the impact of hot-flash
activity on overall quality of life and to examine whether oxybutynin can diminish this
impact on quality of life.
OUTLINE: Patients are randomized into 1 of 4 groups.
GROUP I (LOW-DOSE OXUBUTYNIN CHLORIDE): Patients receive lower dose oxybutynin chloride
orally (PO) twice a day (BID) on days 8-49 in the absence of unacceptable toxicity.
GROUP II (LOW-DOSE PLACEBO): Patients receive lower dose placebo PO BID on days 8-49 in the
absence of unacceptable toxicity.
GROUP III (HIGH-DOSE OXUBUTYNIN CHLORIDE): Patients receive lower dose oxybutynin chloride PO
BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of
unacceptable toxicity.
GROUP IV (HIGH-DOSE PLACEBO): Patients receive lower dose placebo PO BID on days 8-14 and
higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
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