The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III
NCT ID: NCT04871412
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
20 participants
INTERVENTIONAL
2022-04-04
2029-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Integrative Care (Treatment)
Participants 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
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
Standard Care (Control)
Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The Canadian College of Naturopathic Medicine
OTHER
Lotte & John Hecht Memorial Foundation
OTHER
The Centre for Health Innovation
UNKNOWN
University of Ottawa
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Andrew Seely, MD, PhD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Dugald Seely, ND, MSc
Role: PRINCIPAL_INVESTIGATOR
The Canadian College of Naturopathic Medicine
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Michael Garron Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20200796-01H
Identifier Type: -
Identifier Source: org_study_id
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