CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).

NCT03813381 | Completed

• 1 other identifier: CARE-PRO
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The increasing incidence of Esophageal Adenocarcinoma (EAC) in several Western countries can be primarily ascribed to risk factors such as obesity, chronic gastroesophageal reflux, dietary habits and alcohol intake. Nevertheless, Barrett's Esophagus (BE), remains the main risk factor for EAC. Several studies supports the role played by the gut microbiota on the modulation of metabolic and immunological pathways. An abnormal state of the microbial ecosystem seems to be involved in the promotion and onset of various diseases, including cancer. Recent studies have shown that diet and lifestyle have an important modulatory role as protective or risk factors for oncological diseases. The World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) released a review of the evidence that emerged from published studies in the field of nutrition and cancer prevention and summarized their findings into 10 recommendations. Several studies have also shown that a moderate caloric and/or protein restriction seems to be able to reduce the risk of neoplastic disease development. The primary aim of this study is to evaluate the impact of a lifestyle-oriented intervention on body weight, waist circumference, biomarkers associated with cancer risk, esophageal microbiota composition and adherence to cancer prevention recommendations after 24 months in overweight or obese BE patients. Methods and analysis: Patients are randomly divided into two arms, a control arm (CA) and an interventional arm (IA). The CA receives information about a correct lifestyle to prevent cancer. The IA is involved in the two-year program of moderate caloric and protein restriction. At the time of enrollment, anthropometric measurements will be recorded for each patient and they will be randomized to IA or CA. Blood samples will be obtained from each patient and blood glucose will be determined. Serum metabolic biomarkers will be measured in each serum sample and total proteins will be extracted from fresh frozen esophageal biopsy and will be analyzed to evaluate the insulin signal pathway. To assess esophageal microbiota profiling, total genomic DNA (gDNA) will be extracted from matched fresh frozen biopsy. In order to determine a score of adherence to cancer prevention recommendations, participants will be asked to complete a self-administrated questionnaire reflecting WCRF/AICR recommendations. All the measurements will also occur at the end point, after two years from the enrollment.

Conditions

Barrett's Esophagus; Overweight and Obesity

Keywords

Esophageal adenocarcinoma; Diet; Physical activity; Microbiota

Outcome Measures

Primary Outcomes (1)

• Body weight change

  A 7% weight loss

  Baseline and after 24 months

Secondary Outcomes (10)

• Metabolic serum biomarkers

  Baseline and after 24 months

• Metabolic serum biomarkers

  Baseline and after 24 months

• Metabolic serum biomarkers

  Baseline and after 24 months

• Metabolic serum biomarkers

  Baseline and after 24 months

• Metabolic serum biomarkers

  Baseline and after 24 months

Study Arms (2)

Intervention Arm (IA)

EXPERIMENTAL

Patients randomized in the Intervention Arm (IA) will be given personalized diet based on calorie and protein restriction. Calorie restriction will be up to 600 kcal below patients' energy requirements and the amount of protein will be 0.8g of protein/Kg body weight mostly form plant-origin food.

Behavioral: Calorie and protein restriction diet

Control Arm (CA)

NO INTERVENTION

Participants in the CA will be given information about the importance of a healthy lifestyle in reducing the risk of cancer and will receive a leaflet based on WCRF/AICR recommendations.

Interventions

Calorie and protein restriction diet BEHAVIORAL

Patient in intervention arm will be given individualized dietary advice on the basis of WCRF/AICR recommendations. The aim of healthy dietary advice will be the reduction of patient's total daily calorie intake up to 600 kcal below their energy requirements and 0.8g of protein/Kg body weight mostly form plant-origin food. Patients, periodically, will meet the dietitian for a 45-minute nutritional counselling session and a trained nurse for a 15-minute health coaching session. Each patient in the IA will be involved in at least three 4-hour cooking classes. Patients in the IA, after a medical/cardiac evaluation to assure their physical ability for exercise, will attend Nordic walking sessions of moderate intensity two times per month during the 24 months of intervention.

Intervention Arm (IA)

Eligibility Criteria

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

You may qualify if:

• Histological confirmation of Barrett's esophagus without dysplasia or cancer aged ≥ 18 years with BMI ≥ 25.0 kg/m\^2
• Willingness and ability to perform supervised Nordic walking session twice a month and self-planned physical activity at least 3 times a week
• Signed informed consent

You may not qualify if:

• No histological confirmation of Barrett's esophagus
• Cancer diagnosis within one year before trial begins
• Presence of insulin-dependent diabetes
• Denied informed consent

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

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Related Links

• Related Info

MeSH Terms

Conditions

Barrett Esophagus; Overweight; Obesity; Adenocarcinoma Of Esophagus; Motor Activity

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Stefano Realdon, MD, PhD

  Veneto Institute of Oncology IOV-IRCCS, Padua, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 23, 2019
• Study Start: November 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 16, 2023

Record last verified: 2023-10