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Completed

NCT Number: NCT03813381

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

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.

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Key information

Conditions

Barrett's Esophagus Adenocarcinoma Of Esophagus Barrett Esophagus Behavior Body Weight Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Motor Activity Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Precancerous Conditions Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Body weight change

    Time frame: Baseline and after 24 months

    A 7% weight loss

Secondary outcomes

  1. Metabolic serum biomarkers

    Time frame: Baseline and after 24 months

    Fasting glucose (mg/dl)

  2. Metabolic serum biomarkers

    Time frame: Baseline and after 24 months

    Insulin (pg/ml) and C-peptide (pg/ml), tumor necrosis factor-alpha -TNF-alpha (pg/ml) and Interleukin-6 - IL-6 (pg/ml).

  3. Metabolic serum biomarkers

    Time frame: Baseline and after 24 months

    Insulin-like growth factor - IGF1 (nmol/ml), insulin-like growth factor binding protein 1 and 3 - IGFBP1 (nmol/ml) and IGFBP3 (nmol/ml)

  4. Metabolic serum biomarkers

    Time frame: Baseline and after 24 months

    Leptin (ng/ml)

  5. Metabolic serum biomarkers

    Time frame: Baseline and after 24 months

    Adiponectin (µg/ml)

  6. Insulin resistance index (HOMA-IR)

    Time frame: Baseline and after 24 months

    HOMA-IR index [fasting plasma glucose (mg/dl) × fasting serum insulin(μU/ml)/405]

  7. Expression of proteins involved on insulin and IGF1 receptors signal transduction

    Time frame: Baseline and after 24 months

    Phosphoinositide 3-kinases (PI3K)/Protein kinase B(Akt) pathway; mitogenic (ERK/MAPK) pathway

  8. Esophageal microbiota composition

    Time frame: Baseline and after 24 months

    To assess esophageal microbiota profiling, total gDNA will be extracted from fresh frozen biopsy. Specific primers for the bacterial V3-V4 hypervariable regions of 16S ribosomal ribonucleic acid (rRNA) will be used to amplify bacterial DNA [≈ 500 bases pair (bp)] to be sequenced by Illumina Miseq platform with 300 bp paired-end approach.

  9. Adherence score to World Cancer Research Fund and the American Institute for Cancer Research (WCRF/AICR) recommendations for cancer prevention.

    Time frame: Baseline and after 24 months

    In order to determine a score of adherence to cancer prevention recommendations, participants will be asked to complete a 6-item self-administrated questionnaire reflecting six recommendations provided by the World Cancer Research Fund and the American Institute for Cancer Research (WCRF/AICR).

    A score of 1 will be assigned when the item is met and a score of 0 will be assigned when it is not. An answer that partially satisfies the item will be assigned a score of 0.5. Some recommendation (item) have sub-item (item 3,4 and 5). Even for sub-item the score will be 1-0 with 0.5 for partially satisfied item. For total score of item presenting sub-item, we will consider the score obtained by calculating the average score between the sub-item.

    The final adherence score will derive from the mathematical sum of the individual scores obtained for each item. The maximum expected score will be equal to 6 (full adherence).

  10. Waist circumference reduction

    Time frame: Baseline and after 24 months

    Waist circumference (cm)

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Official study title

The Impact of a Moderate CAlorie and Protein REstriction PROgram (CARE-PRO) as an Efficient and Affordable Therapeutic Strategy in Patients With Barrett's Esophagus.

Acronym: CARE-PRO

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2019
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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