The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II (POISE)

Pioneering Pre- and Post-Operative Integrative Care to Improve Thoracic Cancer Quality of Care - The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial - Stage II

Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings.

The Thoracic POISE project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Esophageal Cancer; Lung Cancer
• Intervention / Treatment: Dietary supplement: Vitamin D3 Drops; Dietary supplement: Coriolus Versicolor; Dietary supplement: Trident SAP 66:33 Lemon; Dietary supplement: Probiotic Pro12; Dietary supplement: Provitalix Pure Whey Protein; Dietary supplement: Theracurmin 2X; Dietary supplement: Green Tea Extract; Other: Nutrition Recommendations; Other: Physical Activity Recommendations; Behavioral: Psychological Recommendations

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anna Fazekas, MA, CCRP; Phone Number: 72841 613-737-8899; Email: afazekas@toh.ca
• Study Contact Backup: Name: Mark Legacy, BSc; Phone Number: 1 613-792-1222; Email: mlegacy@thechi.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Contact: Anna Fazekas, MA, CCRP; Phone Number: 72841 613-737-8899; Email: afazekas@toh.ca
      • Contact: Mark Legacy, BSc; Phone Number: 1 613-792-1222; Email: mlegacy@thechi.ca
      • Principal Investigator: Andrew Seely, MD, PhD, FRCSC
      • Principal Investigator: Dugald Seely, ND, MSc
      • Sub-Investigator: Ellen Conte, ND
      • Sub-Investigator: Tim Asmis, MD, FRCPC
      • Sub-Investigator: Rebecca Auer, MD, FRCSC, FACS
      • Sub-Investigator: Kednapa Thavorn, PhD
      • Sub-Investigator: Christian Finley, MD, FRCPC
      • Sub-Investigator: Tim Ramsay, PhD
      • Sub-Investigator: Salmaan Kanji, BSc, PharmD
      • Sub-Investigator: Dean Fergusson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Adults eligible for complete resection of lung, gastric or esophageal cancer

Exclusion criteria

• Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours
• Any wedge resections of lung cancer
• History of cancer with active treatment in the last 3 years (not including superficial bladder cancer or non-melanoma skin cancer)
• Patients currently receiving care guided by an ND or who have previously seen an ND in the last 3 months
• Pregnant or breastfeeding women*
• Any reason which, in the opinion of the Principal Investigator (or delegate), would prevent the subject from participating in the study
• Use of an investigational drug or participation in an investigational study within 30 days prior to starting the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Care (Treatment); Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation	Dietary supplement: Vitamin D3 Drops; 1,000 - 10,000 units daily based on serum levels for the duration of the study; Other Names: Vitamin D; Dietary supplement: Coriolus Versicolor; 1.5g twice daily for the duration of the study; Dietary supplement: Trident SAP 66:33 Lemon; 3g once daily for the duration of the study; Other Names: Fish Oil; Dietary supplement: Probiotic Pro12; 12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery); Other Names: Probiotics; Dietary supplement: Provitalix Pure Whey Protein; 1 scoop (22g) once daily during the peri-operative period (approximately 1 month pre and post-surgery) and during any adjuvant chemotherapy and radiation treatments; Other Names: Protein Powder; Dietary supplement: Theracurmin 2X; 1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation; Other Names: Curcumin; Dietary supplement: Green Tea Extract; 700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.; Other Names: EGCG; Other: Nutrition Recommendations; Based on the Mediterranean diet and lower glycemic index foods; Other: Physical Activity Recommendations; 150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days; Behavioral: Psychological Recommendations; Activities with the intention of actively improving the participant's mental and emotional health
No Intervention: Standard Care (Control); Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Recruitment Rates	Measured by the number of people who are enrolled in the study compared to the total number screened.	At the end of recruitment (estimated 1 year)
Participant Retention Rates	Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.	2 Years
Cross-over and contamination in the control arm - Supplement usage	Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Information on the number of supplements used and the length of use use will be collected at each standard of care visit.	1 Year
Cross-over and contamination in the control arm - Mediterranean Diet Scores	Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Mediterranean diet scores (scale of 0-9) will be calculated in the control group using the Harvard Food Frequency Questionnaire to assess for changes over the 1 year follow up period.	1 year
Cross-over and contamination in the control arm - Physical Activity levels	Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.	1 Year
Cross-over and contamination in the control arm - Psychological Health Activities	Measured by the number of participants in the control arm who perform activities in which the goal of the activity was to improve mental and emotional health.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication	Assessing the type and frequency of communications between research staff at The Ottawa Hospital (TOH) and the Centre for Health Innovation (CHI), as well as within TOH and the CHI through number of emails, phone calls, meetings (in-person or virtual) or any other communication method.	2 years
Natural Killer Cell Function	Measured by serum Interferon Gamma Levels	Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Qualitative Experience	Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews	2 years
Inflammatory Response	Measured by serum C-Reactive Protein Levels	Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery
Neutrophil to Lymphocyte Ratio	Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels	Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: University of Ottawa; The Canadian College of Naturopathic Medicine; Lotte & John Hecht Memorial Foundation; The Centre for Health Innovation
• Investigators: Principal Investigator: Andrew Seely, MD, PhD, FRCSC, Ottawa Hospital Research Institute; Principal Investigator: Dugald Seely, ND, MSc, The Canadian College of Naturopathic Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Surgery; Nutrition; Psychological Health; Natural Health Products; Thoracic Cancer; Integrative Care
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols; Curcumin
• Other Study ID Numbers: 20200796-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No