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NCT Number: NCT04871412

The Thoracic Peri-Operative Integrative Surgical Care Evaluation 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.

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Key information

Conditions

Lung Cancer Behavior Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Personal Satisfaction Psychological Well-Being Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Ottawa Hospital, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3 Drops

Dietary Supplement

1,000 - 10,000 units daily based on serum levels for the duration of the study

Other names: Vitamin D

Coriolus Versicolor

Dietary Supplement

1.5g twice daily for the duration of the study

Trident SAP 66:33 Lemon

Dietary Supplement

3g once daily for the duration of the study

Other names: Fish Oil

Probiotic Pro12

Dietary Supplement

12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)

Other names: Probiotics

Provitalix Pure Whey Protein

Dietary 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

Other names: Protein Powder

Theracurmin 2X

Dietary Supplement

1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation

Other names: Curcumin

Green Tea Extract

Dietary Supplement

700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.

Other names: EGCG

Nutrition Recommendations

Other

Based on the Mediterranean diet and lower glycemic index foods

Physical activity recommendations

Other

150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days

Psychological Recommendations

Behavioral

Activities with the intention of actively improving the participant's mental and emotional health

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Communication

    Time frame: 2 years

    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. Natural Killer Cell Function

    Time frame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery

    Measured by serum Interferon Gamma Levels

  3. Qualitative Experience

    Time frame: 2 years

    Evaluate the qualitative experience of care of participants in both arms through semi-structured interviews

  4. Inflammatory Response

    Time frame: Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery

    Measured by serum C-Reactive Protein Levels

  5. Neutrophil to Lymphocyte Ratio

    Time frame: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery

    Measured by collecting a complete blood count with differential and comparing neutrophil and lymphocyte levels

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Fazekas, MA, CCRP

CONTACT

[email protected]

613-737-8899 ext. 72841

Mark Legacy, BSc

CONTACT

[email protected]

613-792-1222 ext. 1

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Lotte & John Hecht Memorial Foundation
  • The Canadian College of Naturopathic Medicine
  • The Centre for Health Innovation
  • University of Ottawa

Registry information

Official study 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

Acronym: POISE

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
May 4, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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