Combined Exercise and Nutritional Intervention in GI Cancer Patients

Study Overview
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Brief Summary
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Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a positive influence on chemotherapy response and 2) preserve or improve skeletal muscle, thus preventing cancer cachexia. Furthermore, we believe that the neoadjuvant treatment period could be a window of opportunity to optimize patient's nutritional status before surgery, which until now has been under used. Bearing in mind that nutritional interventions may also influence IL-6, our hypothesis is that a Combined Exercise and Dietary Intervention (CEDI) may induce positive alterations in cytokine profile and increase NK cell infiltration of the tumor in gastric and pancreatic cancer patients submitted to neo-adjuvant therapy.

Official Title
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Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.

Conditions
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Exercise, Pancreatic Cancer, Gastric Cancer, Diet

Intervention / Treatment
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* Behavioral: Combined Exercise and Dietary Intervention (CEDI)
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy, age higher than 40 years and lower than 80 years, ECOG (Eastern Cooperative Oncology Group) functional status: 0-2, sedentary/low physical activity level. Exclusion Criteria: life expectancy less than 12 months at inclusion, chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer, metastatic disease, chronic anti-inflammatory medication use, known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis) cardiovascular, respiratory or musculoskeletal or joint problems that preclude moderate physical activity.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Exercise and Dietary Intervention<br>Intervention aimed at conveying a supervised combined moderate aerobic and resistance training, once a week with a duration of 40-60 minutes plus daily home exercise, personalized according to patients' age and functional status. Dietary intervention aimed at a one-on-one nutritional counseling. In the first visit a dietary plan is designed and one daily oral nutritional supplement (Fortimel Compact®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake. | Behavioral: Combined Exercise and Dietary Intervention (CEDI)<br>* The exercise program will be planned by an exercise physiologist and implemented by physiotherapists prior to rehabilitation physician assessment. In the first session patients will be evaluated by physiotherapist in order to allow personalization of exercise according to patient's age and functional capacity. In regard to diet, written materials will be given to patients and caregivers, namely a dietary plan, standard menus, recipes, and standard portions information.<br>|
| Other: Control<br>Standard Care | Behavioral: Standard Care<br>* Standard Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in interleukin 6 (IL6) | IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Immune cell infiltration profile on tumor specimen | Peri-tumoral cell distribution (NK cells, T cells) will be determined before and after combined exercise and dietary intervention (CEDI) | 8 weeks | 
| Change in skeletal muscle | Skeletal muscle using CT scan body composition analysis will be assessed before and after combined exercise and dietary intervention (CEDI) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body composition, Wasting, Malnutrition