NCT05305820

Perioperative Exercise and Nutritional Optimisation Prehabilitation Before Surgery for Patients With Peritoneal Malignancy

The PANO Trial: Perioperative Exercise and Nutrition Optimisation Prehabilitation in Cancer Patients With Peritoneal Malignancy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Dublin City University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

People who are diagnosed with cancer of the colon/rectum/appendix/ovaries that spreads into the lining of the tummy and some ovarian cancers or people with pseudomyxoma peritonei can often undergo intensive treatment including major surgery where chemotherapy is given whilst the person is having surgery - also known by doctors as surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Fitness for this surgery can improve if people undertake a prehabilitation programme at the time they get their diagnosis. To date, little research has focused on how exercise and nutrition support before surgery can help these patients during recovery. The aim of this study is to explore the use of exercise and nutritional support pre-treatment to enhance physical and psychological outcomes for patients.

Detailed description

The comparator in this study will be standard oncological care. Control patients will receive the same care as standard without the addition of a formal exercise and nutrition support programme. The pre-treatment (prehabilitation) programme will commence following diagnosis and continue up to the point of surgery and recommence for six weeks following surgery when deemed clinically fit to participate. Assessments will occur at baseline, pre-surgery, post-surgery, and 6 weeks later and a follow up... Mixed methods will be employed with patients taking part in self-report assessments, physical assessments, and qualitative interviews. The primary aim of the study is to assess the feasibility of the intervention and cardiorespiratory fitness pre-surgery. The secondary aims include assessing the effect of the intervention on physical health, psychological wellbeing, health-related quality of life, self-efficacy, nutrition, and serology markers. Exploratory aims also include post-operative morbidity, health economics analysis and qualitative interview of patient experience.

Conditions

• Peritoneal Malignancy
• Ovarian Cancer
• Rectum Cancer
• Appendix Cancer
• Colon Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	Standard Exercise Program- Participants will be invited to take part in a structured home, supervised, or both, exercise program while undergoing treatment and for a six-week period when deemed fit post-surgery.
BEHAVIORAL	Nutrition	Participants will be screened for their nutritional health and tailored advice and education will be provided on an individualised basis. An online dietary recall tool will be used to track patients' dietary habits. This will occur from diagnosis until point of surgery and recommence for 6 weeks post-surgery once deemed physically fit.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2022-03-31
• Last updated: 2024-03-21

Locations

3 sites across 1 country: Ireland