Testing Vitamin D3 Drops with Coriolus Versicolor for lung cancer
Official title: 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
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
Canadian Sites (2)
The Ottawa Hospital
Ottawa, Ontario, Canada
Michael Garron Hospital
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Adults eligible for complete resection of lung, gastric or esophageal cancer
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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
- +Any reason which, in the opinion of the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (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
- +Pregnant or breastfeeding women\*
Exclusion
- −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
- −Any reason which, in the opinion of the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (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
- −Pregnant or breastfeeding women\*
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Vitamin D3 Drops, Coriolus Versicolor, Trident SAP 66:33 Lemon, Probiotic Pro12, and 6 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 20 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: At the end of recruitment (estimated 1 year).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Participant Recruitment Rates — measured over At the end of recruitment (estimated 1 year).
Participant Retention Rates — measured over 2 Years.
Cross-overCrossoverEach participant receives both treatments in turn, in a set order.Read more → and contamination in the control armControl groupThe group a new treatment is measured against.Read more → - Supplement usage — measured over 1 Year.
Cross-over and contamination in the control armArmOne of the groups in a study, each receiving something different.Read more → - Mediterranean Diet Scores — measured over 1 year.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04871412 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Vitamin D3 DropsDietary supplement
1,000 - 10,000 units daily based on serum levels for the duration of the study
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Coriolus VersicolorDietary supplement
1.5g twice daily for the duration of the study
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Trident SAP 66:33 LemonDietary supplement
3g once daily for the duration of the study
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Probiotic Pro12Dietary supplement
12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Provitalix Pure Whey ProteinDietary 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
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Theracurmin 2XDietary supplement
1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Green Tea ExtractDietary supplement
700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Nutrition RecommendationsOther
Based on the Mediterranean diet and lower glycemic index foods
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Physical Activity RecommendationsOther
150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Psychological RecommendationsBehavioural
Activities with the intention of actively improving the participant's mental and emotional health
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At the end of recruitment (estimated 1 year).
The study as a whole is currently expected to finish around 2029-12-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 20 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Ottawa, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.