NCT04871412

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Gastric Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3 Drops	1,000 - 10,000 units daily based on serum levels for the duration of the study
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
DIETARY_SUPPLEMENT	Probiotic Pro12	12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
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
DIETARY_SUPPLEMENT	Theracurmin 2X	1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
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	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

Timeline

• Start date: 2022-04-04
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2021-05-04
• Last updated: 2026-01-30

Locations

2 sites across 1 country: Canada