NCT05420259

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Hospital Beatriz Ângelo · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Gastric Cancer
• Diet
• Exercise

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Standard Care	Standard Care

Timeline

• Start date: 2022-03-21
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2022-06-15
• Last updated: 2024-03-19

Locations

2 sites across 1 country: Portugal