Understanding the effects of exercise on the body’s responses to complex abdominal cancer surgery

Mechanistic understanding of how preoperative exercise improves perioperative outcomes: a substudy of the NHMRC-funded PRIORITY trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12622000018718

Enrollment

Registered

2022-01-11

Start date

2022-03-01

Completion date

2024-01-01

Last updated

2023-09-26

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 substudy is to better understand the effects of exercise on a number of the body’s responses to complex cancer surgery, including immune effects and the performance of certain organs, such as the heart and brain. Who is it for? You may be eligible for this study if you are an adult who is undergoing complex surgery for treatment of cancers of the gastro-intestinal tract and has already been enrolled in the PRIORITY trial (as described in registration ACTRN12621000617864). Study details In addition to taking part in the PRIORITY trial, participants in this sub-study will be asked to provide blood samples before and after their operation. They will also be asked to complete additional questionnaires before and after their operation to assess for any changes to brain function. Participants will then be asked to complete those questionnaires again one year after their surgery. It is hoped that this study will help researchers to understand the biological reasons why exercise and fitness influences a person’s ability to recover from major surgery, including whether or not they suffer complications following their operation. The ability to answer this question is an important research target because it will advance an understanding of interventions that can be offered to patients to reduce the risks associated with undergoing complex surgery.

Interventions

Patients included in this substudy will be recruited from the PRIORITY trial (Preoperative exercise for patients undergoing major abdominal cancer surgery). PRIORITY is an NHMRC-funded multicentre randomised controlled trial, investigating primarily the effects of a structured preoperative exercise program on in-hospital complications following major abdominal cancer surgery. For complete details regarding the PRIORITY trial, please see registration ACTRN12621000617864. This substudy will collect plasma biomarkers from a sample of the PRIORITY cohort, intending to recruit 144 patients for the purposes of this study. The first 144 patients recruited to PRIORITY will be invited to participate in this substudy. Biomarkers will be collected at the following timepoints: (i) within the week preceding planned surgery, and (ii) postoperatively on each day for the first 4 days following surgery. We will also screen for delirium before and after surgery and assess cognition at baseline and at 1 year following surgery.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

(i) recruited to the PRIORITY trial. There are no additional eligibility criteria for this substudy.

Exclusion criteria

(i) unable to provide informed consent

Outcome results