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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Vitamin D3 Drops
  1,000 - 10,000 units daily based on serum levels for the duration of the study
• Пищевая добавка Coriolus Versicolor
  1.5g twice daily for the duration of the study
• Пищевая добавка Trident SAP 66:33 Lemon
  3g once daily for the duration of the study
• Пищевая добавка Probiotic Pro12
  12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
• Пищевая добавка 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
• Пищевая добавка Theracurmin 2X
  1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
• Пищевая добавка Green Tea Extract
  700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.
• Другое Nutrition Recommendations
  Based on the Mediterranean diet and lower glycemic index foods
• Другое Physical Activity Recommendations
  150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days
• Поведенческое Psychological Recommendations
  Activities with the intention of actively improving the participant's mental and emotional health

Первичные конечные точки

• Participant Recruitment Rates [Срок оценки: At the end of recruitment (estimated 1 year)]
• Participant Retention Rates [Срок оценки: 2 Years]
• Cross-over and contamination in the control arm - Supplement usage [Срок оценки: 1 Year]
• Cross-over and contamination in the control arm - Mediterranean Diet Scores [Срок оценки: 1 year]
• Cross-over and contamination in the control arm - Physical Activity levels [Срок оценки: 1 Year]
• Cross-over and contamination in the control arm - Psychological Health Activities [Срок оценки: 1 Year]

Вторичные конечные точки (5)

• Communication [Срок оценки: 2 years]
• Natural Killer Cell Function [Срок оценки: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery]
• Qualitative Experience [Срок оценки: 2 years]
• Inflammatory Response [Срок оценки: Enrolment, 2-3 days pre-op, and 1 day, 3-4 weeks, 6 months, and 12 months post-surgery]
• Neutrophil to Lymphocyte Ratio [Срок оценки: Enrolment, 2-3 days pre-op, and 6 months and 12 months post surgery]

Критерии участия

Критерии включения

• Adults eligible for complete resection of lung, gastric or esophageal cancer

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

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

Идентификаторы

NCT: NCT04871412 · 20200796-01H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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