Combined Exercise and Nutritional Intervention in GI Cancer Patients

Pancreatic Cancer Clinical Trial

Official title:

Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420259
• Other study ID #: 213/18
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: June 28, 2024

Study information

• Verified date: March 2024
• Source: Hospital Beatriz Ângelo
• Contact: Sónia Velho
• Phone: +351914644141
• Email: soniavelho0[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet
• Exercise
• Gastric Cancer
• Pancreatic Cancer

Intervention

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.
• Standard Care
Standard Care

Locations

Country	Name	City	State
Portugal	Hospital da Luz	Lisboa
Portugal	Hospital Beatriz Ângelo	Loures	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in interleukin 6 (IL6)	IL6 circulating levels will be determined before and after combined exercise and dietary intervention (CEDI)	8 weeks
Secondary	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)	8 weeks
Secondary	Change in skeletal muscle	Skeletal muscle using CT scan body composition analysis will be assessed before and after combined exercise and dietary intervention (CEDI)	8 weeks