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

NCT ID: NCT04871412

Last Updated: 2026-01-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2029-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer Gastric Cancer Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Vitamin D3 Drops

Intervention Type DIETARY_SUPPLEMENT

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

Coriolus Versicolor

Intervention Type DIETARY_SUPPLEMENT

1.5g twice daily for the duration of the study

Trident SAP 66:33 Lemon

Intervention Type DIETARY_SUPPLEMENT

3g once daily for the duration of the study

Probiotic Pro12

Intervention Type DIETARY_SUPPLEMENT

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

Provitalix Pure Whey Protein

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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

Green Tea Extract

Intervention Type DIETARY_SUPPLEMENT

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

Nutrition Recommendations

Intervention Type OTHER

Based on the Mediterranean diet and lower glycemic index foods

Physical Activity Recommendations

Intervention Type OTHER

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

Psychological Recommendations

Intervention Type BEHAVIORAL

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

Group Type NO_INTERVENTION

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

Intervention Type DIETARY_SUPPLEMENT

Coriolus Versicolor

1.5g twice daily for the duration of the study

Intervention Type DIETARY_SUPPLEMENT

Trident SAP 66:33 Lemon

3g once daily for the duration of the study

Intervention Type DIETARY_SUPPLEMENT

Probiotic Pro12

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Theracurmin 2X

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

Intervention Type DIETARY_SUPPLEMENT

Green Tea Extract

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

Intervention Type DIETARY_SUPPLEMENT

Nutrition Recommendations

Based on the Mediterranean diet and lower glycemic index foods

Intervention Type 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

Intervention Type OTHER

Psychological Recommendations

Activities with the intention of actively improving the participant's mental and emotional health

Intervention Type BEHAVIORAL

Other Intervention Names

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Vitamin D Fish Oil Probiotics Protein Powder Curcumin EGCG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role collaborator

Lotte & John Hecht Memorial Foundation

OTHER

Sponsor Role collaborator

The Centre for Health Innovation

UNKNOWN

Sponsor Role collaborator

University of Ottawa

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Michael Garron Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anna Fazekas, MA, CCRP

Role: CONTACT

613-737-8899 ext. 72841

Mark Legacy, BSc

Role: CONTACT

613-792-1222 ext. 1

Facility Contacts

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Anna Fazekas, MA, CCRP

Role: primary

613-737-8899 ext. 72841

Mark Legacy, BSc

Role: backup

613-792-1222 ext. 1

Negar Ahmadi, MD, MSc, MPH

Role: primary

416-317-6133

Other Identifiers

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20200796-01H

Identifier Type: -

Identifier Source: org_study_id

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