Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02596867
Eligibility Criteria:
Inclusion Criteria:
* Ages 18- 65
* diagnosis of stage I-III breast cancer , confirmed by a core biopsy
* Planning to undergo definitive surgery including mastectomy or breast conserving surgery
* Systolic blood pressure must be \>100 mmHg but no more than 140 mmHg and/or diastolic \> 60 mmHg and no more than 95 mmHg.
* normal baseline EKG
Exclusion criteria:
* Pregnancy; potential subjects of female bearing age will have to complete a pregnancy test during screening to ensure that they are not pregnant. Potential patients who are post-menopausal must have confirmed one year without menstrual cycle.
* Free of major medical illnesses including:
* Uncontrolled Diabetes (HbA1c of ≤ 8 if previously tested)
* Uncontrolled hypertension: BP \>systolic 140/ diastolic \> 95
* Cardiac diseases (history of cardiac valve disease, coronary artery disease, congestive heart failure, A-V block, peripheral vascular disease, any cardiac arrhythmia/bradycardia) with the exception of the diagnosed cancer.
* Histories of asthma, bronchospastic disease, or obstructive pulmonary disease
* Previously diagnosed thyrotoxicosis
* Severe allergic reactions to medications which are included in the beta blocker family
* Previously or currently treated with a beta adrenergic receptor antagonist
* Patients with locally advanced or inflammatory breast cancer not amenable to surgical resection
* Patients taking any of the following medications will be excluded:
* Drugs that are categorized as digitalis glycosides, beta-blockers and calcium channel blockers, ACE inhibitors and alpha blockers
* Amiodarone
* Cimetidine
* Ciprofloxacin
* Delavudin
* Dobutamine
* Ethanol
* Fluconazole
* Fluoxetine
* Fluvoxamine
* Haloperidol
* Imipramine
* Isoniazid
* Isoproterenol
* Luvoxamine
* Paroxetine
* Phenytoin
* Phenobarbital.
* Propafenone.
* Quinidine
* Reserpine
* Rifampin
* Ritonavir
* Rizatriptan.
* Tenioposide
* Theophylline
* Thyroxine
* Tolbutamide.
* Warfarin
* Zileuton
* Zolmitriptan
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02596867
Study Brief:
Protocol Section:
NCT02596867