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

ConditionsLung CancerGastric CancerEsophageal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D3 Drops

    Dietary supplement

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

  • 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

  • Probiotic Pro12

    Dietary supplement

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

  • 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

  • Theracurmin 2X

    Dietary supplement

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

  • Green Tea Extract

    Dietary supplement

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

  • Nutrition Recommendations

    Other intervention

    Based on the Mediterranean diet and lower glycemic index foods

  • Physical Activity Recommendations

    Other intervention

    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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Integrative Care (Treatment)Experimental treatment 10 interventions
Group B: Standard Care (Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Participant Recruitment Rates

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

Time frame
At the end of recruitment (estimated 1 year)
2

Participant Retention Rates

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

Time frame
2 Years
3

Cross-over and contamination in the control arm - Supplement usage

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.

Time frame
1 Year
4

Cross-over and contamination in the control arm - Mediterranean Diet Scores

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.

Time frame
1 year

Secondary outcomes

1

Communication

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.

Time frame
2 years
2

Natural Killer Cell Function

Measured by serum Interferon Gamma Levels

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

Qualitative Experience

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

Time frame
2 years
4

Inflammatory Response

Measured by serum C-Reactive Protein Levels

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

Other outcomes

Sponsors and contacts

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Ottawa Hospital Research Institute

Lead sponsor

The Canadian College of Naturopathic Medicine

Collaborator

Lotte & John Hecht Memorial Foundation

Collaborator

The Centre for Health Innovation

Collaborator

University of Ottawa

Collaborator

Source ClinicalTrials.gov
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