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

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ClinicalTrials.gov Identifier: NCT03813381
Recruitment Status : Unknown
Verified January 2019 by Stefano Realdon, Istituto Oncologico Veneto IRCCS.
Recruitment status was:  Enrolling by invitation
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Stefano Realdon, Istituto Oncologico Veneto IRCCS

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE November 25, 2015
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2019)
Body weight change [ Time Frame: Baseline and after 24 months ]
A 7% weight loss
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2019)
  • Metabolic serum biomarkers [ Time Frame: Baseline and after 24 months ]
    Fasting glucose (mg/dl)
  • 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).
  • 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)
  • Metabolic serum biomarkers [ Time Frame: Baseline and after 24 months ]
    Leptin (ng/ml)
  • Metabolic serum biomarkers [ Time Frame: Baseline and after 24 months ]
    Adiponectin (µg/ml)
  • 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]
  • 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
  • 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.
  • 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).
  • Waist circumference reduction [ Time Frame: Baseline and after 24 months ]
    Waist circumference (cm)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Barrett's Esophagus
  • Overweight and Obesity
Intervention  ICMJE Behavioral: Calorie and protein restriction diet

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.

Study Arms  ICMJE
  • Experimental: Intervention Arm (IA)
    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.
    Intervention: Behavioral: Calorie and protein restriction diet
  • No Intervention: Control Arm (CA)
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 20, 2019)
190
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03813381
Other Study ID Numbers  ICMJE CARE-PRO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stefano Realdon, Istituto Oncologico Veneto IRCCS
Study Sponsor  ICMJE Istituto Oncologico Veneto IRCCS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefano Realdon, MD, PhD Veneto Institute of Oncology IOV-IRCCS, Padua, Italy
PRS Account Istituto Oncologico Veneto IRCCS
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP