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

NCT05305820 | Active Not Recruiting DMC

• 1 other identifier: COALESE/2021/103
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Peritoneal Malignancy

Outcome Measures

Primary Outcomes (4)

• Feasibility of Adherence to the Intervention

  Prehabilitation fidelity in terms of the patient group adherence as measured by patient structured qualitative feedback and activity logs.

  2-6 weeks pre surgery, 6 weeks post-surgery

• Feasibility of participant retention to the Intervention

  Prehabilitation fidelity in terms of the patient group retention as measured by patient screening and retention logs and monitoring of recruitment rates.

  2-6 weeks pre-surgery, 6 weeks post-surgery

• Feasibility of intervention effectiveness

  Prehabilitation fidelity in terms of intervention effectiveness as measured by qualitative patient feedback at two timepoints. Monitoring of patient activity logs. Engagement with online and in-person exercise and nutritional intervention resources.

  2-6 weeks pre-surgery, 6 weeks post-surgery

• Change in Cardiorespiratory Fitness

  Cardiorespiratory fitness using the 6-Minute Walk Test (6MWT) assessed at the pre-surgery time point. The 6MWT is performed with participants walking up and down a 20 m course marked by cones for 6 min under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions is used as per the European Respiratory Society guidelines. The 6MWT is a validated assessment of cardiorespiratory function in clinical populations.

  2-6 weeks pre-surgery, 6 weeks post-surgery

Secondary Outcomes (14)

• Change in Strength - The Handgrip Test

  2-6 weeks pre-surgery, 6 weeks post-surgery

• Change in Strength - The Stand to Sit Test

  2-6 weeks pre-surgery, 6 weeks post-surgery

• Change in Activity - 3-day ActivPAL3 triaxial accelerometer

  2-6 weeks pre-surgery, 6 weeks post-surgery

• Change in Psychological Stress

  2-6 weeks pre-surgery, 6 weeks post-surgery

• Change in Psychological Stress- Impact of Events Scale

  2-6 weeks pre-surgery, 6 weeks post surgery

Other Outcomes (8)

• Post-operative Morbidity- Post-surgery Morbidity Score

  Day 2 post

• Post-operative Morbidity- The Clavien-Dindo classification

  Day 15 post

• Post-Operative Morbidity- Comprehensive Complication Index

  Day 15 post

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Exercise; Behavioral: Nutrition

Control

NO INTERVENTION

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

Interventions

Exercise BEHAVIORAL

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.

Also known as: Tailored Exercise Prehabilitation Program

Intervention

Nutrition BEHAVIORAL

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.

Also known as: Nutritional Optimisation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dublin City University: lead
• Mater Misericordiae University Hospital: collaborator
• Royal College of Surgeons, Ireland: collaborator

Study Sites (3)

Dublin City University

Dublin, Ireland

Location

Mater Misericordiae university hospital

Dublin, Ireland

Location

Royal College of Surgeons , Ireland

Dublin, Ireland

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Rectal Neoplasms; Appendiceal Neoplasms; Colonic Neoplasms

Interventions

Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Cecal Neoplasms; Cecal Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Jurgen Mulsow, Mr.

  Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

• Lisa Loughney, Dr.

  Royal College of Surgeons, Ireland

  PRINCIPAL INVESTIGATOR

• Lorraine Boran, Dr.

  Dublin City University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It will not be possible to be blinded to the to the allocation of participants due to their active involvement in the behavioural exercise and nutritional interventions during the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: Parallel group randomised 1:1 controlled multi-centre trial

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 31, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

IE (3)