Combined Exercise and Nutritional Intervention in GI Cancer Patients

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer; Diet; Exercise; Gastric Cancer
• Interventions: Behavioral: Combined Exercise and Dietary Intervention (CEDI); Behavioral: Standard Care

• Registration Number: NCT05420259
• Lead Sponsor: Hospital Beatriz Ângelo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Exercise and Dietary Intervention	Combined Exercise and Dietary Intervention (CEDI)	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.
Control	Standard Care	Standard Care

Primary Outcome Measures

Name	Time	Method
Mean Change in interleukin 6 (IL6)	8 weeks	IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI)

Secondary Outcome Measures

Name	Time	Method
Change in Immune cell infiltration profile on tumor specimen	8 weeks	Peri-tumoral cell distribution (NK cells, T cells) will be determined before and after combined exercise and dietary intervention (CEDI)
Change in skeletal muscle	8 weeks	Skeletal muscle using CT scan body composition analysis will be assessed before and after combined exercise and dietary intervention (CEDI)

Trial Locations

Locations (2)

Hospital Beatriz Ângelo; 🇵🇹 Loures, Lisboa, Portugal

Hospital da Luz; 🇵🇹 Lisboa, Portugal