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

Dublin City University

Status: Active, not recruiting

Conditions: Appendix Cancer; Peritoneal Malignancy; Rectum Cancer; Colon Cancer; Ovarian Cancer

Treatments: Behavioral: Exercise; Behavioral: Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05305820

COALESE/2021/103 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years,
• multidisciplinary team referral for CRS-HIPEC for colorectal/appendix/ovarian peritoneal disease or pseudomyxoma peritonei (+/- completed neoadjuvant cancer treatment)
• WHO performance status ≤2.

Exclusion criteria

• inability to provide informed consent,
• impaired cognitive function with a reduced ability to either understand advice /instructions from or communicate with the research team,
• declined surgery,
• surgery in less than 2 weeks
• pregnancy or breastfeeding,
• inability to participate in the exercise training (unable to perform the 6 Minute Walk Test)
• absolute contraindications to exercise testing, veganism.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Intervention

Experimental group

Description:

Exercise: The exercise training program was designed to improve physical fitness prior to surgery and for a 6-week period after surgery once deemed fit. Nutrition: The nutritional arm consists of nutritional intervention tailored to the outcome of the nutritional screening.Participants will be asked to take part in a dietary food recall system called Foodbook24, and based on their dietary needs will be supported in nutritional optimisation.

Treatment:

Behavioral: Nutrition

Behavioral: Exercise

Control

No Intervention group

Description:

This group will receive standard oncological care and will receive no formal education of exercise or nutritional intervention.