Lung CancerPhase 3POISENCT04871412
The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III
A Phase 3 study testing Vitamin D3 Drops, Coriolus Versicolor and Trident SAP 66:33 Lemon in people with Lung Cancer and Gastric Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Gastric Cancer, Esophageal Cancer
- What is being tested?
- Vitamin D3 Drops, Coriolus Versicolor and Trident SAP 66:33 Lemon
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Apr 2022to 1 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults eligible for complete resection of lung, gastric or esophageal cancer
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Anna Fazekas, MA, CCRP, 613-737-8899 ext. 72841, afazekas@toh.ca
Mark Legacy, BSc, 613-792-1222 ext. 1, mlegacy@thechi.ca
- Recruiting
Michael Garron Hospital
Toronto, Ontario, M4C 3E7
Negar Ahmadi, MD, MSc, MPH, 416-317-6133, Negar.Ahmadi@tehn.ca
About this study
Official title: 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
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
- Being tested
- Vitamin D3 Drops, Coriolus Versicolor, Trident SAP 66:33 Lemon, Probiotic Pro12, Provitalix Pure Whey Protein
- Keywords
- Natural Health Products, Thoracic Cancer, Surgery, Integrative Care, Nutrition, Physical Activity, Psychological Health
- Medical subject headings
- Lung Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 DropsDietary supplement
Also called Vitamin D
1,000 - 10,000 units daily based on serum levels for the duration of the study
Coriolus VersicolorDietary supplement
1.5g twice daily for the duration of the study
Trident SAP 66:33 LemonDietary supplement
Also called Fish Oil
3g once daily for the duration of the study
Probiotic Pro12Dietary supplement
Also called Probiotics
12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
Provitalix Pure Whey ProteinDietary supplement
Also called Protein Powder
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 2XDietary supplement
Also called Curcumin
1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
Green Tea ExtractDietary supplement
Also called EGCG
700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.
Nutrition RecommendationsOther
Based on the Mediterranean diet and lower glycemic index foods
Physical Activity RecommendationsOther
150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days
Psychological RecommendationsBehavioural
Activities with the intention of actively improving the participant's mental and emotional health
| Study group | Role | What they receive |
|---|---|---|
| Integrative Care (Treatment) | Experimental | 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 Receives: Dietary Supplement: Vitamin D3 Drops; Dietary Supplement: Coriolus Versicolor; Dietary Supplement: Trident SAP 66:33 Lemon; Dietary Supplement: Probiotic Pro12; Dietary Supplement: Provitalix Pure Whey Protein; Dietary Supplement: Theracurmin 2X; Dietary Supplement: Green Tea Extract; Other: Nutrition Recommendations; Other: Physical Activity Recommendations; Behavioral: Psychological Recommendations |
| Standard Care (Control) | No intervention | Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rates
Measured by the number of people who are enrolled in the study compared to the total number screened.
Measured: At the end of recruitment (estimated 1 year)
Participant Retention Rates
Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.
Measured: 2 Years
Cross-over and contamination in the control arm - Supplement usage
Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Information on the number of supplements used and the length of use use will be collected at each standard of care visit.
Measured: 1 Year
Cross-over and contamination in the control arm - Mediterranean Diet Scores
Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Mediterranean diet scores (scale of 0-9) will be calculated in the control group using the Harvard Food Frequency Questionnaire to assess for changes over the 1 year follow up period.
Measured: 1 year
Cross-over and contamination in the control arm - Physical Activity levels
Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.
Measured: 1 Year
Cross-over and contamination in the control arm - Psychological Health Activities
Measured by the number of participants in the control arm who perform activities in which the goal of the activity was to improve mental and emotional health.
Measured: 1 Year
Secondary outcomes (5)
Communication
Assessing the type and frequency of communications between research staff at The Ottawa Hospital (TOH) and the Centre for Health Innovation (CHI), as well as within TOH and the CHI through number of emails, phone calls, meetings (in-person or virtual) or any other communication method.
Measured: 2 years
Natural Killer Cell Function
Measured by serum Interferon Gamma Levels
Measured: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Qualitative Experience
Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews
Measured: 2 years
Inflammatory Response
Measured by serum C-Reactive Protein Levels
Measured: Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery
Neutrophil to Lymphocyte Ratio
Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels
Measured: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start4 Apr 2022
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Canadian College of Naturopathic Medicine, Lotte & John Hecht Memorial Foundation, The Centre for Health Innovation, University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Andrew Seely, MD, PhD, FRCSC, Principal investigator, Ottawa Hospital Research InstituteDugald Seely, ND, MSc, Principal investigator, The Canadian College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871412
- Sponsor's protocol ID
- 20200796-01H
- Acronym
- POISE
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04871412
- Acronym / sponsor ID
- POISE / 20200796-01H
- Conditions
- Lung Cancer, Gastric Cancer, Esophageal Cancer
- Keywords
- Natural Health Products, Thoracic Cancer, Surgery, Integrative Care, Nutrition, Physical Activity, Psychological Health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Canadian College of Naturopathic Medicine, Lotte & John Hecht Memorial Foundation, The Centre for Health Innovation, University of Ottawa
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Care (Treatment) | Experimental | Dietary Supplement: Vitamin D3 Drops, Dietary Supplement: Coriolus Versicolor, Dietary Supplement: Trident SAP 66:33 Lemon, Dietary Supplement: Probiotic Pro12, Dietary Supplement: Provitalix Pure Whey Protein, Dietary Supplement: Theracurmin 2X, Dietary Supplement: Green Tea Extract, Other: Nutrition Recommendations, Other: Physical Activity Recommendations, Behavioral: Psychological RecommendationsParticipants 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 |
| Standard Care (Control) | No intervention | –Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults eligible for complete resection of lung, gastric or esophageal cancer
Key exclusion criteria (7 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 DropsAlso: Vitamin D1,000 - 10,000 units daily based on serum levels for the duration of the study | Dietary supplement | Integrative Care (Treatment) |
| Coriolus Versicolor1.5g twice daily for the duration of the study | Dietary supplement | Integrative Care (Treatment) |
| Trident SAP 66:33 LemonAlso: Fish Oil3g once daily for the duration of the study | Dietary supplement | Integrative Care (Treatment) |
| Probiotic Pro12Also: Probiotics12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery) | Dietary supplement | Integrative Care (Treatment) |
| Provitalix Pure Whey ProteinAlso: Protein Powder1 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 | Integrative Care (Treatment) |
| Theracurmin 2XAlso: Curcumin1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation | Dietary supplement | Integrative Care (Treatment) |
| Green Tea ExtractAlso: EGCG700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments. | Dietary supplement | Integrative Care (Treatment) |
| Nutrition RecommendationsBased on the Mediterranean diet and lower glycemic index foods | Other | Integrative Care (Treatment) |
| Physical Activity Recommendations150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days | Other | Integrative Care (Treatment) |
| Psychological RecommendationsActivities with the intention of actively improving the participant's mental and emotional health | Behavioural | Integrative Care (Treatment) |
Primary outcome
Participant Recruitment Rates
Time frame: At the end of recruitment (estimated 1 year)
Measured by the number of people who are enrolled in the study compared to the total number screened.
Participant Retention Rates
Time frame: 2 Years
Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.
Cross-over and contamination in the control arm - Supplement usage
Time frame: 1 Year
Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Information on the number of supplements used and the length of use use will be collected at each standard of care visit.
Cross-over and contamination in the control arm - Mediterranean Diet Scores
Time frame: 1 year
Measured by the number of participants in the control arm who use the integrative interventions outlined in the protocol independent of a naturopathic doctor. Mediterranean diet scores (scale of 0-9) will be calculated in the control group using the Harvard Food Frequency Questionnaire to assess for changes over the 1 year follow up period.
Cross-over and contamination in the control arm - Physical Activity levels
Time frame: 1 Year
Changes in physical activity will be monitored using the International Physical Activity Questionnaire, which is used to calculate total metabolic equivalent task (MET) minutes.
Cross-over and contamination in the control arm - Psychological Health Activities
Time frame: 1 Year
Measured by the number of participants in the control arm who perform activities in which the goal of the activity was to improve mental and emotional health.
5 secondary outcomes
Communication
Time frame: 2 years
Natural Killer Cell Function
Time frame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Qualitative Experience
Time frame: 2 years
Inflammatory Response
Time frame: Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery
Neutrophil to Lymphocyte Ratio
Time frame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Seely, MD, PhD, FRCSC principal investigator
Ottawa Hospital Research Institute
Dugald Seely, ND, MSc principal investigator
The Canadian College of Naturopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 Drops, Coriolus Versicolor and Trident SAP 66:33 Lemon in people with Lung Cancer and Gastric Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Fazekas, MA, CCRP (613-737-8899 ext. 72841, afazekas@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rates (time frame: At the end of recruitment (estimated 1 year)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.