Oxybutynin Chloride in Managing Hot Flashes
A Phase III, Double-Blind, Controlled Trial of Oxybutynin in the Management of Hot Flashes
3 other identifiers
interventional
150
1 country
13
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2016
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedStudy Start
First participant enrolled
December 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2018
CompletedResults Posted
Study results publicly available
June 3, 2019
CompletedJanuary 18, 2020
August 1, 2018
1.4 years
November 9, 2016
April 16, 2019
January 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo
Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity.
Baseline up to day 49
Secondary Outcomes (5)
Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo
Baseline up to day 49
Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo
Baseline up to day 49
Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo
Baseline up to day 49
Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo
Baseline up to day 49
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
Up to 7 weeks
Study Arms (4)
Group I (low-dose oxybutynin chloride)
EXPERIMENTALPatients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
Group II (low-dose placebo)
PLACEBO COMPARATORPatients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
Group III (high-dose oxybutynin chloride)
EXPERIMENTALPatients 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)
PLACEBO COMPARATORPatients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
Interventions
Given PO
Given PO
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, 61801, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Saint Elizabeth Medical Center South
Edgewood, Kentucky, 41017, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Waverly Hematology Oncology
Cary, North Carolina, 27518, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Saint Vincent Hospital -Green Bay
Green Bay, Wisconsin, 54301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles L. Loprinzi, M.D
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Loprinzi
Academic and Community Cancer Research United
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2016
First Posted
November 11, 2016
Study Start
December 9, 2016
Primary Completion
April 27, 2018
Study Completion
April 27, 2018
Last Updated
January 18, 2020
Results First Posted
June 3, 2019
Record last verified: 2018-08