Clinical trial NCT05305820: Perioperative Exercise and Nutritional Optimisation Prehabilitation Before Surgery for Patients With Peritoneal Malignancy
Official title: The PANO Trial: Perioperative Exercise and Nutrition Optimisation Prehabilitation in Cancer Patients With Peritoneal Malignancy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peritoneal Malignancy
Ovarian Cancer
Rectum Cancer
Appendix Cancer
Colon Cancer
Keywords: Peritoneal Malignancy
Lead sponsor: Dublin City University
Sponsor class: OTHER
Collaborators: name: Mater Misericordiae University Hospital
name: Royal College of Surgeons, Ireland
First posted: 2022-03-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomised 1:1 controlled multi-centre trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Adherence to the Intervention
timeFrame: 2-6 weeks pre surgery, 6 weeks post-surgery
measure: Feasibility of participant retention to the Intervention
timeFrame: 2-6 weeks pre-surgery, 6 weeks post-surgery
measure: Feasibility of intervention effectiveness
timeFrame: 2-6 weeks pre-surgery, 6 weeks post-surgery
measure: Change in Cardiorespiratory Fitness
timeFrame: 2-6 weeks pre-surgery, 6 weeks post-surgery
Secondary outcomes:
measure: Change in Strength - The Handgrip Test
timeFrame: 2-6 weeks pre-surgery, 6 weeks post-surgery
measure: Change in Strength - The Stand to Sit Test
timeFrame: 2-6 weeks pre-surgery, 6 weeks post-surgery
measure: Change in Activity - 3-day ActivPAL3 triaxial accelerometer
timeFrame: 2-6 weeks pre-surgery, 6 weeks post-surgery
measure: Change in Psychological Stress
timeFrame: 2-6 weeks pre-surgery, 6 weeks post-surgery
measure: Change in Psychological Stress- Impact of Events Scale
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Cognitive Reserve-Cognitive Reserve Index (CR-IQ)
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Cognition- FACT-Cog
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Self-Efficacy
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Health Related Quality of Life (HrQoL)-EQ-5D-5L (5L)
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Health Related Quality of Life (HrQoL)- FACT-G
timeFrame: 2-6 weeks surgery, 6 weeks post surgery
measure: Change in Nutritional Status-The Malnutrition Screening Tool
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Nutritional Status- Glasgow Prognostic Score
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Dietary Intake - Foodbook24
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Change in Nutritional Status- Blood Screening
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
Other outcomes:
measure: Post-operative Morbidity- Post-surgery Morbidity Score
timeFrame: Day 2 post
measure: Post-operative Morbidity- The Clavien-Dindo classification
timeFrame: Day 15 post
measure: Post-Operative Morbidity- Comprehensive Complication Index
timeFrame: Day 15 post
measure: Post-Operative Morbidity - Length of Hospital Stay
timeFrame: Day 1-15 post surgery
measure: Health Economic- Exploratory Analysis
timeFrame: 2-6 weeks pre surgery, 6 weeks post surgery
measure: Serology Markers- Exploratory Analysis
timeFrame: 2-6 weeks pre-surgery, 6 weeks post surgery
measure: Qualitative Experience - Qualitative Patient Experience
timeFrame: 2-6 weeks pre surgery- 6 weeks post surgery
measure: Change in Smoking Status
timeFrame: 2-6 weeks pre surgery, 6 weeks post surgery
Locations:
city: Dublin
country: Ireland
facility: Dublin City University
city: Dublin
country: Ireland
facility: Mater Misericordiae university hospital
city: Dublin
country: Ireland
facility: Royal College of Surgeons , Ireland
Study officials:
affiliation: Mater Misericordiae University Hospital
name: Jurgen Mulsow, Mr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of Surgeons, Ireland
name: Lisa Loughney, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dublin City University
name: Lorraine Boran, Dr.
role: PRINCIPAL_INVESTIGATOR
References: