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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04871412
Other study ID # 20200796-01H
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 4, 2022
Est. completion date December 1, 2025

Study information

Verified date May 2023
Source Ottawa Hospital Research Institute
Contact Anna Fazekas, MA, CCRP
Phone 613-737-8899
Email afazekas@toh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.
Other:
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
Behavioral:
Psychological Recommendations
Activities with the intention of actively improving the participant's mental and emotional health

Locations

Country Name City State
Canada The Ottawa Hospital Ottawa Ontario

Sponsors (5)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Lotte & John Hecht Memorial Foundation, The Canadian College of Naturopathic Medicine, The Centre for Health Innovation, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participant Recruitment Rates Measured by the number of people who are enrolled in the study compared to the total number screened. At the end of recruitment (estimated 1 year)
Primary Participant Retention Rates Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms. 2 Years
Primary 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. 1 Year
Primary 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. 1 year
Primary 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. 1 Year
Primary 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. 1 Year
Secondary 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. 2 years
Secondary Natural Killer Cell Function Measured by serum Interferon Gamma Levels Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
Secondary Qualitative Experience Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews 2 years
Secondary Inflammatory Response Measured by serum C-Reactive Protein Levels Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery
Secondary Neutrophil to Lymphocyte Ratio Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery
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