Combined Exercise and Nutritional Intervention in GI Cancer Patients

NCT05420259 | Recruiting

• 1 other identifier: 213/18
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer; Gastric Cancer; Diet; Exercise

Keywords

Body composition; Wasting; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Mean Change in interleukin 6 (IL6)

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

  8 weeks

Secondary Outcomes (2)

• Change in Immune cell infiltration profile on tumor specimen

  8 weeks

• Change in skeletal muscle

  8 weeks

Study Arms (2)

Combined Exercise and Dietary Intervention

EXPERIMENTAL

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.

Behavioral: Combined Exercise and Dietary Intervention (CEDI)

Control

OTHER

Standard Care

Behavioral: Standard Care

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.

Combined Exercise and Dietary Intervention

Standard Care BEHAVIORAL

Standard Care

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Beatriz Ângelo: lead

Study Sites (2)

Hospital Beatriz Ângelo

Loures, Lisbon District, 2674-514, Portugal

RECRUITING

Hospital da Luz

Lisbon, Portugal

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms; Motor Activity; Cachexia; Malnutrition

Interventions

Diet Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Behavior; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marilia Cravo

  Hospital da Luz

  STUDY DIRECTOR

Central Study Contacts

Sónia Velho

CONTACT

+351914644141; soniavelho0@gmail.com

Marilia Cravo

CONTACT

919439192; marilia.cravo@sapo.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutricionist

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 15, 2022
• Study Start: March 21, 2022
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

PT (2)