Combined Exercise and Nutritional Intervention in GI Cancer Patients
NCT ID: NCT05420259
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2022-03-21
2024-06-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Combined Exercise and Dietary Intervention
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.
Combined Exercise and Dietary Intervention (CEDI)
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.
Control
Standard Care
Standard Care
Standard Care
Interventions
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Combined Exercise and Dietary Intervention (CEDI)
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.
Standard Care
Standard Care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Hospital Beatriz Ângelo
OTHER
Responsible Party
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Sónia Velho
Nutricionist
Principal Investigators
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Marilia Cravo
Role: STUDY_DIRECTOR
Hospital da Luz
Locations
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Hospital Beatriz Ângelo
Loures, Lisbon District, Portugal
Hospital da Luz
Lisbon, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Sónia Velho
Role: primary
Other Identifiers
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213/18
Identifier Type: -
Identifier Source: org_study_id
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