Preoperative Immunonutrition in Patients Undergoing Pelvic Exenteration Surgery for Cancer

Patients with cancer undergoing pelvic exenterations will receive either immunonutrition supplements or the equivalent in protein and energy of other nutrition supplements to determine any difference between post operative complications.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000308594

Enrollment

121

Registered

2015-04-01

Start date

2015-08-06

Completion date

2018-01-18

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine if immunonutrition prior to pelvic exenteration surgery for people with cancer decreases complications, length of hospital stay and immune markers after their surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are scheduled to undergo pelvic exenteration surgery for cancer. Study details - Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will consume 3 immunonutrition supplements (known as Impact Advanced Recovery) each day for 5 days prior to their surgery. Participants in the other group will instead consume 3 nutrition supplements with equivalent protein and energy as the immunonutrition supplements (3 x Resource Protein) each day for 5 days prior to their operation. All participants will be monitored for up to 3 months post hospital discharge for any post-operative complications, such as infectious or non-infectious complications and immune markers.

Interventions

Intervention group will consume 1 immunonutrition supplement (178mL) 3 times day day for 5 days prior to their surgery. For one immunonutrition supplement (178mL) Key Active Ingredients: Arginine - 4.2g Omega-3 Fatty Acids - ALA 1.1g - EPA 672mg - DHA 432mg Nucleotides - 430mg Energy and Protein: Energy - 200 calories Protein - 18g All patients will fill out a compliance record form, which is a tick sheet outlining whether or not they have consumed each supplement. If they have not consu

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

People who are undergoing pelvic exenteration surgery for cancer

Exclusion criteria

-People who are under 18 -People who are unable to consent due to language barriers or cognitive function - People who are unable to consume nutrition supplements 5 days prior to their operation or - People who are undergoing a pelvic exenteration that is NOT for curative measures

Outcome results