RecruitingPhase 3NCT04871412

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


Sponsor

Ottawa Hospital Research Institute

Enrollment

20 participants

Start Date

Apr 4, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • • Adults eligible for complete resection of lung, gastric or esophageal cancer

Exclusion Criteria7

  • 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

Interventions

DIETARY_SUPPLEMENTVitamin D3 Drops

1,000 - 10,000 units daily based on serum levels for the duration of the study

DIETARY_SUPPLEMENTCoriolus Versicolor

1.5g twice daily for the duration of the study

DIETARY_SUPPLEMENTTrident SAP 66:33 Lemon

3g once daily for the duration of the study

DIETARY_SUPPLEMENTProbiotic Pro12

12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)

DIETARY_SUPPLEMENTProvitalix 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_SUPPLEMENTTheracurmin 2X

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

DIETARY_SUPPLEMENTGreen Tea Extract

700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.

OTHERNutrition Recommendations

Based on the Mediterranean diet and lower glycemic index foods

OTHERPhysical Activity Recommendations

150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days

BEHAVIORALPsychological 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

View Full Details on ClinicalTrials.gov

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NCT04871412


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