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

Ottawa Hospital Research Institute

Status and phase: Enrolling; Phase 3

Conditions: Esophageal Cancer; Gastric Cancer; Lung Cancer

Treatments: Dietary Supplement: Green Tea Extract; Dietary Supplement: Theracurmin 2X; Dietary Supplement: Provitalix Pure Whey Protein; Dietary Supplement: Probiotic Pro12; Other: Nutrition Recommendations; Other: Physical Activity Recommendations; Behavioral: Psychological Recommendations; Dietary Supplement: Trident SAP 66:33 Lemon; Dietary Supplement: Vitamin D3 Drops; Dietary Supplement: Coriolus Versicolor

Study type: Interventional

Funder types: Other

Identifiers

NCT04871412

20200796-01H

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Integrative Care (Treatment)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Coriolus Versicolor

Dietary Supplement: Trident SAP 66:33 Lemon

Dietary Supplement: Vitamin D3 Drops

Behavioral: Psychological Recommendations

Other: Physical Activity Recommendations

Other: Nutrition Recommendations

Dietary Supplement: Probiotic Pro12

Dietary Supplement: Provitalix Pure Whey Protein

Dietary Supplement: Theracurmin 2X

Dietary Supplement: Green Tea Extract

Standard Care (Control)

No Intervention group

Description:

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