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The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III
Sponsor: Ottawa Hospital Research Institute
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.
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 III
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-04-04
Completion Date
2029-12-01
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
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.
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
Psychological Recommendations
Activities with the intention of actively improving the participant's mental and emotional health
Locations (2)
The Ottawa Hospital
Ottawa, Ontario, Canada
Michael Garron Hospital
Toronto, Ontario, Canada