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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Barrett's Esophagus Overweight and Obesity Behavioral: Calorie and protein restriction diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : November 25, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Body weight change [ Time Frame: Baseline and after 24 months ]
    A 7% weight loss


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813381


Sponsors and Collaborators
Istituto Oncologico Veneto IRCCS
Investigators
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Principal Investigator: Stefano Realdon, MD, PhD Veneto Institute of Oncology IOV-IRCCS, Padua, Italy
  Study Documents (Full-Text)

Documents provided by Stefano Realdon, Istituto Oncologico Veneto IRCCS:
Study Protocol and Statistical Analysis Plan  [PDF] November 11, 2014

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:
World Cancer Research Fund/American Institute for Cancer Research. Continuous Update Project Report: Diet, Nutrition, Physical Activity and Oesophageal Cancer. 2016. Available at: wcrf.org/oesophageal-cancer-2016. 2016. http://wcrf.org/oesophageal-cancer-2016.
Compare D, G. N. The bacteria-hypothesis of colorectal cancer: pathogenetic and therapeutic implications. Transl Gastrointest Cancer 2013;3:44-53. doi:10.3978/j.issn.2224-4778.2013.05.37
World Cancer Research Fund/American Institute for Cancer Research, Research AI for C. Food, Nutrition, Physical Activity, and the Prevention of Cancer: a Global Perspective. Washington DC: : American Institute for Cancer Research 2007.
Romaguera D, Vergnaud AC, Peeters PH, van Gils CH, Chan DS, Ferrari P, Romieu I, Jenab M, Slimani N, Clavel-Chapelon F, Fagherazzi G, Perquier F, Kaaks R, Teucher B, Boeing H, von Rüsten A, Tjønneland A, Olsen A, Dahm CC, Overvad K, Quirós JR, Gonzalez CA, Sánchez MJ, Navarro C, Barricarte A, Dorronsoro M, Khaw KT, Wareham NJ, Crowe FL, Key TJ, Trichopoulou A, Lagiou P, Bamia C, Masala G, Vineis P, Tumino R, Sieri S, Panico S, May AM, Bueno-de-Mesquita HB, Büchner FL, Wirfält E, Manjer J, Johansson I, Hallmans G, Skeie G, Benjaminsen Borch K, Parr CL, Riboli E, Norat T. Is concordance with World Cancer Research Fund/American Institute for Cancer Research guidelines for cancer prevention related to subsequent risk of cancer? Results from the EPIC study. Am J Clin Nutr. 2012 Jul;96(1):150-63. doi: 10.3945/ajcn.111.031674. Epub 2012 May 16.

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Responsible Party: Stefano Realdon, Head of Digestive Endoscopy Unit, Istituto Oncologico Veneto IRCCS
ClinicalTrials.gov Identifier: NCT03813381    
Other Study ID Numbers: CARE-PRO
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefano Realdon, Istituto Oncologico Veneto IRCCS:
Esophageal adenocarcinoma
Diet
Physical activity
Microbiota
Additional relevant MeSH terms:
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Barrett Esophagus
Overweight
Body Weight
Precancerous Conditions
 Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases