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

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

Overview

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.

Interventions

• Dietary supplement Vitamin D3 Drops
  1,000 - 10,000 units daily based on serum levels for the duration of the study
• Dietary supplement Coriolus Versicolor
  1.5g twice daily for the duration of the study
• Dietary supplement Trident SAP 66:33 Lemon
  3g once daily for the duration of the study
• Dietary supplement Probiotic Pro12
  12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
• 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
• Dietary supplement Theracurmin 2X
  1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
• Dietary supplement 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
• 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
• Behavioral Psychological Recommendations
  Activities with the intention of actively improving the participant's mental and emotional health

Primary outcome measures

• 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]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 2 centers

• The Ottawa Hospital — Ottawa
• Michael Garron Hospital — Toronto

Identifiers

NCT: NCT04871412 · 20200796-01H

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗