RecruitingNot ApplicableNCT05420259

Combined Exercise and Nutritional Intervention in GI Cancer Patients

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


Sponsor

Hospital Beatriz Ângelo

Enrollment

68 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combined exercise and nutrition program for people with stomach (gastric) or pancreatic cancer who are receiving chemotherapy before surgery. The goal is to improve physical strength, nutritional status, and overall fitness, which may help patients tolerate treatment better and recover faster. **You may be eligible if...** - You have been diagnosed with Stage II or III gastric or pancreatic cancer - You are scheduled to receive neoadjuvant chemotherapy (chemo before surgery) - You are between 40 and 80 years old - You are currently sedentary or have a low level of physical activity - You are well enough to participate in light-to-moderate physical activity **You may NOT be eligible if...** - Your life expectancy is less than 12 months - You have a physical or cognitive condition that prevents safe exercise or following a nutritional plan - You have already started chemotherapy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCombined 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.

BEHAVIORALStandard Care

Standard Care


Locations(2)

Hospital da Luz

Lisbon, Portugal

Hospital Beatriz Ângelo

Loures, Lisbon District, Portugal

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NCT05420259


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