None listed
Conditions
Brief summary
Surgery to remove solid tumours is the most commonly prescribed and effective treatment for most cancers of this presentation. However, major cancer surgery represents a stressor to the patient which results in a relative immunosuppression that can be seen in a reduction in the number and immune activity of natural killer cells. This study aims to assess the feasibility of boosting cancer patients' immunity prior to surgery through a combination of a pre-surgery flu vaccination and dietary supplements. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with an abdominal cancer requiring surgery, colorectal cancer, sarcoma, upper gastrointestinal cancer, liver or gallbladder cancer or genitourinary cancer (e.g. bladder/penile/cervical/uterine/ovarian cancers). Study details Participants who choose to enrol in this study will be allocated by computer randomisation to one of two treatment groups. The first group will be given a flu vaccine the day before on on the day of their scheduled surgery, and will be asked to take a dietary supplement (arginine) each day for the 5 days before and 5 days after their surgery. The second group will not receive a flu vaccine or the dietary supplement and will undergo their scheduled surgery only. The third group will have no intervention (control group). Participants in all groups will be asked to provide up to 5 blood samples for testing. It is hoped this research will determine whether it is practical to administer flu vaccines and dietary supplements to patients prior to a major abdominal cancer surgery. The preliminary results collected from this small study will also be used to determine whether it is worthwhile pursuing a larger clinical trial to investigate the effect of these strategies on immune activity in a larger population of cancer patients.
Interventions
This randomised control trial will include participants undergoing abdominopelvic cancer surgery only
Arm 1: Control - no intervention
Arm 2: Influenza vaccine only:
1. Seasonal quadrivalent influenza vaccine, 0.5mL - administered 1 day prior to abdomino-pelvic cancer surgery or on day of surgery, administered by doctor.
Arm 3: Influenza vaccine and arginine immunonutrition:
1. Seasonal quadrivalent influenza vaccine, 0.5mL - administered 1 day prior to abdomino-pelvic cancer surgery or on day o
This randomised control trial will include participants undergoing abdominopelvic cancer surgery only Arm 1: Control - no intervention Arm 2: Influenza vaccine only: 1. Seasonal quadrivalent influenza vaccine, 0.5mL - administered 1 day prior to abdomino-pelvic cancer surgery or on day of surgery, administered by doctor. Arm 3: Influenza vaccine and arginine immunonutrition: 1. Seasonal quadrivalent influenza vaccine, 0.5mL - administered 1 day prior to abdomino-pelvic cancer surgery or on day of surgery, adminsitered by doctor. 2. Dietary supplementation of oral arginine - 4.5g twice daily (powder to be diluted in 200ml water), prescribed 5 days before and after surgery
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: • Male or female • Age >18 years. • Elective surgery • Major intra-abdominal cancer surgery, including: o Colorectal o Sarcoma o Upper gastrointestinal o Hepatobiliary o Genitourinary
Exclusion criteria
• History of allergy or anaphylaxis to previous influenza vaccine • Contraindication to the influenza vaccine • Patients on immunotherapy: Including: Immune checkpoint inhibitors; T-cell therapy; Monoclonal antibodies; Treatment vaccines and Immune system modulators (modulating therapy e.g., cytokines such as Interferon, interleukin, haematopoietic growth factors such as erythropoietin, IL-11, G-CSF; BCG, thalidomide, lanalidomide, monoclonal antibodies (mabs, mibs), steroids • History of allergy or anaphylaxis to arginine or arginine supplemented products • Participants who have already received a dose of the influenzae vaccine for that calendar year • Palliative surgery for end-stage disease with no curative intent • Patients with existing metastatic disease • Emergency surgery • Extensive comorbid disease, i.e. ASA > 3 • Age <18 years old • Refusal or inability to provide valid informed consent • Currently enrolled in another clinical trial unless agreed by the CPI and PI that co-enrolment can occur.
Outcome results
None listed