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Combined Exercise and Nutritional Intervention in GI Cancer Patients

NCT05420259 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-03-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospital Beatriz Ângelo

    lead OTHER

Principal Investigators

  • Marilia Cravo · Hospital da Luz

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2024-06-28
Completion
2024-06-28

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05420259 on ClinicalTrials.gov