Oxybutynin Chloride in Managing Hot Flashes

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)
- Gabapentin
- Clonidine
- Agents with known anticholinergic activity
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:
- Gastroparesis or gastrointestinal obstructive disorders
- Significant gastric reflux symptoms
- 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Charles Loprinzi, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials