Combined Exercise and Nutritional Intervention in GI Cancer Patients

N/AUnknownNCT05420259

Hospital Beatriz Ângelo68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Gastric Cancer Diet

Interventions

Combined Exercise and Dietary Intervention (CEDI)BEHAVIORAL

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 CareBEHAVIORAL

Standard Care

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean Change in interleukin 6 (IL6)

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

Time frame: 8 weeks

Secondary Outcomes

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)

Time frame: 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)

Time frame: 8 weeks

Combined Exercise and Nutritional Intervention in GI Cancer Patients

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts