None listed
Conditions
Brief summary
This study will investigate whether, in patients receiving breast cancer surgery, pre-operative Propranolol compared with placebo, changes the cancer's gene expression. Who is it for? You may be eligible to join this study if you are a female aged 18-70 years old, have histologically-confirmed breast cancer and will undergo breast cancer surgery at Peter MacCallum Cancer Centre. Study details Participants will be randomly allocated (by chance) to one of two treatment groups. Patients in one group will receive Propranolol for 7 days prior to their scheduled breast cancer surgery while patients in the other group will receive a placebo tablet over the same period. Tablets will be taken two times a day. To determine the results of the study, the researchers will compare blood tests and tumour samples (biopsy and excision samples) obtained before and after administration of the study medication (at the time of surgery). In the samples, the investigators will be looking for the behaviour of specific ‘anti-cancer’ immune cells in the blood and in the tissue surrounding and controlling the tumour. The investigators will also be analysing the immune cells to understand the biological effects of the ‘stress’ that a patient may be experiencing. The information from this study will be presented to clinicians and researchers and will provide very useful information to guide a larger study examining the role of propranolol in all patients receiving breast surgery or in those patients where breast cancer has spread.
Interventions
Arm 1:Propranolol
Trade/Product/Code Name
Deralin (Unregistered Trademark)
Dosage form
Tablet
Presentation
40 mg tablet (red, film coated, marked PP/40, G on reverse)
Route of administration
Oral
Formulation
Propranolol hydrochloride
Participants in the study will be given 7 days of pre-operative Propranolol (or placebo equivalent) prior to and including the day of surgery and then will be titrated off Propranolol over two days in the postoperative period.
Day AM dose PM dose
-7 40mg
Arm 1:Propranolol Trade/Product/Code Name Deralin (Unregistered Trademark) Dosage form Tablet Presentation 40 mg tablet (red, film coated, marked PP/40, G on reverse) Route of administration Oral Formulation Propranolol hydrochloride Participants in the study will be given 7 days of pre-operative Propranolol (or placebo equivalent) prior to and including the day of surgery and then will be titrated off Propranolol over two days in the postoperative period. Day AM dose PM dose -7 40mg 40mg -6 40mg 40mg -5 40mg 40mg -4* 80mg 80mg -3 80mg 80mg -2 80mg 80mg -1 80mg 80mg 0 80mg 40mg +1 40mg 40mg +2 40mg 40mg (0 = Day of surgery) Arm 2: Matched Placebo Compliance: Assessed through i) Second daily phone calls ii) Assessed pill return iii) Pill diary (for participants to self administer) iv) Quantification of propranolol dosing on day of surgery
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Written, informed consent; - Female subjects with histologically-confirmed breast cancer, who will undergo surgical excision at PMCC at least 7 days after enrollment; - Age 18-80 years old; - World Health Organization ECOG performance status 0 or 1;
Exclusion criteria
- Women who are pregnant or breast feeding; - Women with absolute or relative contraindications to Propranolol: Sick sinus syndrome. Sinus bradycardia (less than 60 beats/minute). First, Second or third degree atrioventricular block. Resting blood pressure less than 100/60mmHg. Untreated phaeochromocytoma Untreated thyroid disorder Patients receiving dihydropyridine or non-dihydropyridine Calcium Channel Blocking agents (eg diltiazem, verapamil, nifedipine, amlodipine) Severe peripheral vascular disease (intermittent claudication) Patients receiving anti-arrhythmic agents (eg amiodarone, sotalol, digoxin) Patients with renal impairment (defined as Creatinine greater than 0.15mmol/L) Patients with liver impairment: AST or ALT or ALP > 2.5 x upper limit of normal range (ULN), bilirubin > 1.5 x ULN, ALP > 2.5. Patients receiving Clonidine, Digoxin, Rizatriptan, Cimetidine, Hydralazine, Guanethidine or Ergotamine Episodes of major depression - Breast resection within 6 months of study entry; - Women who have received neoadjuvant chemotherapy prior to the planned breast cancer resection; - Women with histologically demonstrated ductal carcinoma in situ; - Non-English speaking women; - Women using regular (daily) pre-operative anti-inflammatory agents eg NSAIDs and aspirin >100mg/day; - Women using regular anxiolytics (eg benzodiazepines), alpha-receptor adrenergic agonists (eg Clonidine); - Use of selective or non-selective beta-adrenergic inhibitors in the last three months (examples include Propranolol, Metoprolol, Atenolol, Sotalol); - Past history of stroke; - Women with moderate or severe asthma, as defined by previous Intensive Care Unit admission or oral steroid-requiring asthma; - Other medical conditions considered prohibitive by the treating physician (including frailty).
Outcome results
None listed