Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Stomach Neoplasms

Esophageal Neoplasms

Stomach Cancer

Esophageal Cancer

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Vitamins

Other Dietary Supplements

Herbal and Botanical

Vitamin D

Cholecalciferol

Curcumin

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Vitamin D3

Calciferol

Whey Protein

Ergocalciferol

Vitamin D2

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

Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital

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

Vitamin D3 Drops

1.5g twice daily for the duration of the study

Coriolus Versicolor

3g once daily for the duration of the study

Trident SAP 66:33 Lemon

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

Probiotic Pro12

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

Provitalix Pure Whey Protein

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

Theracurmin 2X

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

Green Tea Extract

Based on the Mediterranean diet and lower glycemic index foods

Nutrition Recommendations

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

Physical Activity Recommendations

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

Psychological Recommendations

Anna Fazekas, MA, CCRP

Mark Legacy, BSc

Andrew Seely, MD, PhD, FRCSC

Dugald Seely, ND, MSc

Ellen Conte, ND

Tim Asmis, MD, FRCPC

Rebecca Auer, MD, FRCSC, FACS

Kednapa Thavorn, PhD

Dean Fergusson, PhD

Christian Finley, MD, FRCPC

Tim Ramsay, PhD

Salmaan Kanji, BSc, PharmD

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.

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

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 II

Measured by the number of people who are enrolled in the study compared to the total number screened.

Measured by the number of people who enrol in the study but subsequently withdraw. These numbers will be compared between arms.

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 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.

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 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.

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 by serum Interferon Gamma Levels

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

Measured by serum C-Reactive Protein Levels

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

The Canadian College of Naturopathic Medicine

Lotte & John Hecht Memorial Foundation

The Centre for Health Innovation

University of Ottawa

Ottawa Hospital Research Institute

Maitake

Maitake given alongside systemic chemotherapy and/or CD4/6 inhibitors

Black Maitake Prothera

Mark Legacy

Dugald Seely

Daniel Lander

Adrienne Junek, MD

Maitake is an edible mushroom that is used for both its nutritional and medicinal properties. Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators aim to measure if Maitake has any immunomodulatory effects when given alongside conventional systemic cancer therapy.

Maitake for Integrative Cancer Care

Maitake for Integrative Cancer Care: An Open Label, Uncontrolled Trial in People on Systemic Cancer Therapy

The investigators will assess within-person changes in blood neutrophils throughout the study. Normal limit is 2.00 - 7.50 x 10\^9/L, where a higher neutrophil count will be considered an improvement. Values above the normal limit will be excluded due to the potential of infection.

Febrile neutropenia is defined as absolute neutrophil count \< 1.0 x 10\^9/L and temperature \> 38.3 degrees Celsius.

Higher NLRs have been associated with poorer cancer prognosis. The investigators will assess within-person changes in NLR where a lower value in considered favourable. Values of neutrophils or lymphocytes outside the normal limit will be excluded due to the potential for infection.

Higher PLRs have been associated with poorer cancer prognosis. The investigators will assess within-person changes in PLR where a lower value in considered favourable. Values of lymphocytes outside the normal limit will be excluded due to the potential for infection.

CRP is a measure of inflammation. Higher levels of inflammation have been linked with poorer cancer prognosis. The investigators will assess within-person changes in CRP as a measure of systemic inflammation. Values less than 10 mg/mL are considered normal, with lower values being favourable.

QOL will be evaluated using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C30 (EORTC QLQ C30), version 3.0, a validated tool for analyzing health-related QOL in patients with cancer participating in clinical trials. The questionnaire incorporates five functional scales, (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a global health status, and a number of single items assessing additional symptoms. Scores range from 0-100 for each item. For functional scales and global health status, a higher score is favourable. For all symptom scales, a lower score is favourable.

HbA1c is a measure of blood glucose management, an item which is thought to be modulated by Maitake. The investigators will evaluate within-person changes in this metric as a measure of safety. Values below 5.7% are considered normal, with lower values being favourable.

The investigators will collect any adverse events experienced by participants per the common terminology criteria for adverse events (CTCAE) version 5.0.

The investigators will assess the frequency of dose delays or reductions in chemotherapy or CD4/6 inhibitors during the 16-week study period. Dose reductions or delays in treatment can negatively impact outcomes; not having reductions or delays is favourable.

The investigators will assess the incidence of participants requiring new medications (e.g., granulocyte colony-stimulating factor) prescribed to combat neutropenia throughout the 16-week study period. The addition of new medications can cause adverse effects and potentially delay other conventional treatments. The absence of additional medication is considered favourable.

Participation in an open dialogue about CAM with a nurse specialist. The dialogue will be based on the fundamentals of person-centered care and include patient preferences and wishes, reliable information and counselling, and advice about the potential risks and benefits of using CAM.

The dialogue is estimated to last approximately 60 minutes and all dialogues will be conducted by the same nurse. Depending on patient needs and wishes there may be a follow-up consultation one month after the first dialogue.

Standard care including referral to a homepage about complementary alternative medicine

1-hour dialogue about CAM with a nurse specialist as an Integrated part of conventional oncology care

Open dialogue about complementary alternative medicine

Standard care including referral to a homepage about CAM

Standard care

Lars Henrik Jensen

The purpose of this phase two parallel-group randomized controlled trial is to assess the efficacy of open dialogue about CAM integrated in conventional oncology care. The investigators hypothesize that patients in the intervention group participating in a scheduled open dialogue with a nurse specialist about CAM will experience better physical and mental health compared to patients in the control group receiving standard care alone.

Patients randomized to the intervention group will participate in a scheduled open dialogue about CAM with a specialist nurse, who has completed the Fellowship in Integrative Medicine at the University of Arizona. This is a training program for health professionals in empowering individuals and communities to optimize health and well-being through evidence-based, sustainable and integrative approaches. The open dialogue will be based on the fundamentals of person-centered care according to this program and include patient preferences and wishes, reliable information and counselling and advice about the potential risks and benefits of using CAM as an adjunct to conventional oncology care.

All dialogue, each lasting approximately 60 minutes, will be conducted by the same nurse as soon as possible and at the latest two weeks after enrolment. According to patient needs and wishes there may be a follow-up dialogue over the telephone or in the Oncology Outpatient Clinic. The potential second dialogue is estimated to last approximately 30 minutes.

Participants in the control group will receive standard information including reference to www.KABcancer.dk, which is a website presenting research on CAM, including information about its potential effects and outcomes.

Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care

A Phase Two Parallel-group Randomized Controlled Trial Assessing the Efficacy of Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care

Adverse events are graded according to the Common Terminology Criteria for Adverse Events (CTCAEv5)

Quality of life will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30). The EORTC is composed of both multi item scales and single item measures. These include five functional scales, three symptom scales, a global health status and six single items. All of the scales and single items measures range in score from 0 to 100. A high score for functional scale represents a high/health level of functioning. A high score for the global health status represents a high quality of life. A high score for a symptom scale represents a high level of symptomatology/problems

Evaluation of received information will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Information Questionnaire (EORTC QLQ-INFO25).

Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS)

Frequency of adverse events grade 3-4 will be measured by using Common Terminology Criteria for Adverse Events (CTCAEv5)

Vejle Hospital

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Broad-based, multi-agent integrative care program delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care.

Standardized supplemental/natural health product, physical, nutritional and mental/emotional recommendations based on the phases of standard care (neo-adjuvant, perioperative, adjuvant and long-term maintenance).

Integrative Care

Dugald MR Seely, ND, MSc

Andrew JE Seely, MD, PhD

Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative care intervention delivered by naturopathic doctors in conjunction with standard surgical and oncologic care of people with thoracic cancer.

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.

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. This multi-stage project aims to design, pilot-test and evaluate a broad-based, multi-agent, evidence-based integrative care program to be delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. It is hypothesized that this integrative care program will improve HRQoL as well as reduce surgical adverse events and improve cancer survival. Stage I of the project will pilot-test the intervention and outcomes collection in a single-arm, feasibility study.

The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I

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 I

Collection of adverse events related to surgery, adjuvant therapy, and the interventions

Functional Assessment of Cancer Therapy-General Score

Plasma concentrations of a panel of cytokines (IL2, IL10, TGF-beta, TNF-alpha, IFN-alpha, and IFN-gamma) will be measured in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery

NK cell activity will be measured by NKVue™ in blood samples collected 4 weeks before surgery, 2-3 days before surgery, on post-operative day (POD) 1, POD 5 (+/-2), 3-4 weeks, 6 months and 1 year post-surgery

Percentage of participants who complete all assessments and integrative care appointments

Count of missed doses assessed by patient diary.

Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery

Extent of adherence to physical activity recommendations assessed using a patient diary.

Number of days audio-recordings were used assessed by patient diary.

Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant

Semi-structured interviews with thematic analysis

Percentage of participants recruited out of potentially eligible patients invited.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage II	NCT04871412	Lung Cancer Gastric Cancer Esophageal Canc...	Vitamin D3 Drop... Coriolus Versic... Trident SAP 66:... Probiotic Pro12 Provitalix Pure... Theracurmin 2X Green Tea Extra... Nutrition Recom... Physical Activi... Psychological R...	18 Years -	Ottawa Hospital Research Institute
Maitake for Integrative Cancer Care	NCT06323473	Cancer	Black Maitake P...	18 Years -	The Canadian College of Naturopathic Medicine
Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care	NCT03857776	Cancer	Open dialogue a... Standard care	18 Years -	Vejle Hospital
Maitake for Integrative Cancer Care	NCT06323473	Cancer	Black Maitake P...	18 Years -	The Canadian College of Naturopathic Medicine
The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I	NCT02845479	Lung Neoplasms Esophageal Neop... Stomach Neoplas...	Integrative Car...	18 Years -	The Canadian College of Naturopathic Medicine

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