Recruiting
Phase 3

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04871412

Conditions

Lung Cancer

Gastric Cancer

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin D3 Drops

Coriolus Versicolor

Trident SAP 66:33 Lemon

Probiotic Pro12

Provitalix Pure Whey Protein

Study Details

Brief 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

Study ID

NCT04871412

Start date

Apr 4, 2022

Status verified date

Jan, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: Standard Care (Control)

Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital

Interventions

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

Primary outcome measure

  • Participant Recruitment Rates [ Time Frame: At the end of recruitment (estimated 1 year) ]
  • Participant Retention Rates [ Time Frame: 2 Years ]
  • Cross-over and contamination in the control arm - Supplement usage [ Time Frame: 1 Year ]
  • Cross-over and contamination in the control arm - Mediterranean Diet Scores [ Time Frame: 1 year ]
  • Cross-over and contamination in the control arm - Physical Activity levels [ Time Frame: 1 Year ]
  • Cross-over and contamination in the control arm - Psychological Health Activities [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Anna Fazekas, MA, CCRP

613-737-8899afazekas@toh.ca

Mark Legacy, BSc

613-792-1222mlegacy@thechi.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Anna Fazekas, MA, CCRP

613-737-8899afazekas@toh.ca

Mark Legacy, BSc

613-792-1222mlegacy@thechi.ca

Principal Investigator:

Andrew Seely, MD, PhD, FRCSC

Michael Garron Hospital

Recruiting

Toronto, Ontario, Canada, M4C 3E7

Contacts

Negar Ahmadi, MD, MSc, MPH

416-317-6133Negar.Ahmadi@tehn.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Natural Health Products
  • Thoracic Cancer
  • Surgery
  • Integrative Care
  • Nutrition
  • Physical Activity
  • Psychological Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-01-30.