Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 3 N=150 Randomized Double-blind Supportive Care

Oxybutynin Chloride in Managing Hot Flashes

Breast Carcinoma · Ductal Breast Carcinoma In Situ · Hot Flashes · Lobular Breast Carcinoma In Situ · No Evidence of Disease

Bottom Line

View on ClinicalTrials.gov: NCT02961790 ↗
Enrolled (actual)
150
Serious AEs
1.5%
Results posted
Jun 2019
Primary outcome: Primary: 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 — -16.9; -10.6; -5.7 score on a scale — p=0.0041

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Oxybutynin Chloride (Drug); Placebo (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Academic and Community Cancer Research United
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
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		 -16.9; -10.6; -5.7 0.0041 sig
SECONDARY
Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo		 8.1; 15.6 <0.0001 sig
SECONDARY
Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo		 9.8; 16.2 <0.0001 sig
SECONDARY
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		 0.0; -0.3; -1.4 0.0174 sig
SECONDARY
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		 -2.3; -2.9; -0.2 0.0011 sig
SECONDARY
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)		 1; 1; 0; 0; 0; 0 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02961790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search