Combined Exercise and Nutritional Intervention in GI Cancer Patients

Hospital Beatriz Ângelo

Status: Enrolling

Conditions: Gastric Cancer; Diet; Exercise; Pancreatic Cancer

Treatments: Behavioral: Combined Exercise and Dietary Intervention (CEDI); Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05420259

213/18

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Combined Exercise and Dietary Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Combined Exercise and Dietary Intervention (CEDI)

Control

Other group

Description:

Standard Care

Treatment:

Behavioral: Standard Care