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

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

DIETARY_SUPPLEMENT

Theracurmin 2X

1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation

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

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

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

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine

  collaborator OTHER

• Lotte & John Hecht Memorial Foundation

  collaborator OTHER

• The Centre for Health Innovation

  collaborator UNKNOWN

• University of Ottawa

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Andrew Seely, MD, PhD, FRCSC · Ottawa Hospital Research Institute

• Dugald Seely, ND, MSc · The Canadian College of Naturopathic Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-04

Primary Completion

2028-12-01

Completion

2029-12-01

Countries

• Canada

Study Locations