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

Lung Cancer Clinical Trial

— POISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871412
• Other study ID #: 20200796-01H
• Status: Recruiting
• Phase: Phase 3
• Start date: April 4, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: Ottawa Hospital Research Institute
• Contact: Anna Fazekas, MA, CCRP
• Phone: 613-737-8899
• Email: afazekas[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastric Cancer
• Lung Cancer

Intervention

Dietary Supplement:
• Vitamin D3 Drops
1,000 - 10,000 units daily based on serum levels for the duration of the study
• Coriolus Versicolor
1.5g twice daily for the duration of the study
• Trident SAP 66:33 Lemon
3g once daily for the duration of the study
• Probiotic Pro12
12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
• 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
• Theracurmin 2X
1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
• Green Tea Extract
700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.

Other:
• Nutrition Recommendations
Based on the Mediterranean diet and lower glycemic index foods
• 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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Lotte & John Hecht Memorial Foundation, The Canadian College of Naturopathic Medicine, The Centre for Health Innovation, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Natural Killer Cell Function	Measured by serum Interferon Gamma Levels	Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Secondary	Qualitative Experience	Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews	2 years
Secondary	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
Secondary	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