| Eligibility |
Inclusion Criteria:
- Patients with a diagnosis of a primary abdominal malignancy consented to undergo major
surgery with a planned length of stay of 3 or more days.
- Eligible patients must have signed a consent for surgical resection of the malignancy.
- Adequate hematological function defined as: platelet count = 100 x 109/L, absolute
neutrophil count = 1 x 109/L, white blood count = 2.5 x 109/L, hemoglobin count = 90
g/L.
- Adequate organ functioning, including: total bilirubin = 1.5 x upper limit of normal
(ULN); AST, ALT < 2.5 x ULN; INR <1.5 ; CrCl>30mL/min.
- If sexually active, and of childbearing potential, subjects must agree to use
acceptable birth control from screening until the final study visit (study day, SD35)
or early termination. Acceptable methods of birth control include: spermicide with
condom, diaphragm, or cervical cap, IUD (intrauterine device), hormonal contraception,
vasectomy, and abstinence. (Plan B or the rhythm method are not considered reliable
methods.
- Male subjects should agree to avoid having sex for 5 days before surgery and 10 days
post surgery taking tadalafil due to the risk of sustained erection
- Ability to understand and provide a signed informed consent form (ICF) approved by the
Institutional Review Board (IRB/IEC/REB).
- Ability to comply with protocol requirements.
Exclusion Criteria:
- Prior adjuvant chemotherapy or radiation within 8 weeks of planned surgery.
- Pregnant or nursing mothers or women of childbearing potential not using acceptable
methods of birth control.
- Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS)
and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A).
Subjects may be on physiologic doses of replacement prednisone or equivalent doses of
corticosteroid (<7.5 mg daily).
- History of autoimmune disease (even if controlled with medication) such as but not
restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing
spondylitis, scleroderma, or multiple sclerosis.
- Allergies or any contraindication to the use of tadalafil or any components of Cialis®
or the influenza vaccine (including eggs), Agriflu®.
- Serious intercurrent chronic or acute illness, or other illness considered by the
investigator as an unwarranted high risk for an investigational product.
- Patients who have suffered a myocardial infarction, stroke, or life-threatening
arrhythmia within the last 6 months.
- Patients with resting hypotension (BP <90/50 at rest) or hypertension (BP >170/110 at
rest).
- Patients with cardiac failure or coronary artery disease causing unstable angina.
- Use any type of nitrate drug therapy, including short-acting nitrate-containing
medications, due to the risk of developing potentially life-threatening hypotension.
The use of organic nitrates, either regularly and/or intermittently, in any form (e.g.
oral, sublingual, transdermal, by inhalation) is absolutely contraindicated (see list
Appendix II).
- Use of guanylate cyclase stimulators (cinaciguat or riociguat).
- Use of alpha-blocker therapy (see list in Appendix I).
- Previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) or
history of retinitis pigmentosa.
- Use of anti-platelet (excluding ASA) or anti-coagulation medication (Patients who
discontinue such medications at least 7 days prior to first treatment may be eligible
for this study).
- Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (at least 7
days prior to the first treatment), and PEG-IFN (at least14 days prior to the first
treatment).
- Active infection of any site requiring ongoing treatment.
- Known anatomical deformities of the penis (such as angulation, cavernosal fibrosis or
Peyronie's disease) or any condition that might predispose the patient to priapism.
- History of Guillaine-Barré Syndrome.
- Subjects with a medical or psychological impediment to probable compliance with the
protocol should be excluded.
- Active drug or alcohol use or dependence or other conditions that, in the opinion of
the investigator, would interfere with adherence to study requirements. Social alcohol
use is acceptable.
- Concurrent inhibitors of moderate or strong CYP3A4 inhibitors
- Taking any other PDE-5 inhibitor (such as sildenafil) during the active phase of the
study between enrollment to SD35.
- History of lactose or milk sugar intolerance
- Liver or Kidney disease
- Sickle cell anemia
- Peptic ulcer or other bleeding disorders
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