The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III
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 III
1 other identifier
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 lung-cancer
Started Apr 2022
Typical duration for phase_3 lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedStudy Start
First participant enrolled
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
January 30, 2026
January 1, 2026
6.7 years
April 12, 2021
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (5)
Communication
2 years
Natural Killer Cell Function
Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Qualitative Experience
2 years
Inflammatory Response
Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery
Neutrophil to Lymphocyte Ratio
Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Study Arms (2)
Integrative Care (Treatment)
EXPERIMENTALParticipants 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
Standard Care (Control)
NO INTERVENTIONParticipants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital
Interventions
1,000 - 10,000 units daily based on serum levels for the duration of the study
1.5g twice daily for the duration of the study
3g once daily for the duration of the study
12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
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
1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.
Based on the Mediterranean diet and lower glycemic index foods
150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days
Activities with the intention of actively improving the participant's mental and emotional health
Eligibility Criteria
You may qualify if:
- Adults eligible for complete resection of lung, gastric or esophageal cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Canadian College of Naturopathic Medicinecollaborator
- Lotte & John Hecht Memorial Foundationcollaborator
- The Centre for Health Innovationcollaborator
- University of Ottawacollaborator
- Ottawa Hospital Research Institutelead
Study Sites (2)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Michael Garron Hospital
Toronto, Ontario, M4C 3E7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Seely, MD, PhD, FRCSC
Ottawa Hospital Research Institute
- PRINCIPAL INVESTIGATOR
Dugald Seely, ND, MSc
The Canadian College of Naturopathic Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
May 4, 2021
Study Start
April 4, 2022
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share