Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Stomach Neoplasms

Malnutrition

Wasting Syndrome

Cachexia

Pancreatic Cancer

Stomach Cancer

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.

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.

Combined Exercise and Dietary Intervention (CEDI)

Standard Care

Sónia Velho

Marilia Cravo

Velho

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.

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.

IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI)

Peri-tumoral cell distribution (NK cells, T cells) will be determined before and after combined exercise and dietary intervention (CEDI)

Skeletal muscle using CT scan body composition analysis will be assessed before and after combined exercise and dietary intervention (CEDI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combined Exercise and Nutritional Intervention in GI Cancer Patients	NCT05420259	Pancreatic Canc... Gastric Cancer Diet Exercise	Combined Exerci... Standard Care	40 Years - 80 Years	Hospital Beatriz Ângelo
Combined Exercise and Nutritional Intervention in GI Cancer Patients	NCT05420259	Pancreatic Canc... Gastric Cancer Diet Exercise	Combined Exerci... Standard Care	40 Years - 80 Years	Hospital Beatriz Ângelo

Spots Global Cancer Trial Database for combined exercise and dietary intervention (cedi)