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Barrett's EsophagusCARE-PRONCT03813381

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

A study testing Calorie and protein restriction diet in people with Barrett's Esophagus and Overweight and Obesity, run by Istituto Oncologico Veneto IRCCS.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Barrett's Esophagus, Overweight and Obesity
What is being tested?
Calorie and protein restriction diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
Nov 2015to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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.

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.

Read more

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.

Being tested
Calorie and protein restriction diet
Keywords
Esophageal adenocarcinoma, Diet, Physical activity, Microbiota
Medical subject headings
Barrett Esophagus, Overweight, Obesity, Adenocarcinoma Of Esophagus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calorie and protein restriction dietBehavioural

    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 groups in NCT03813381
Study groupRoleWhat they receive
Intervention Arm (IA)ExperimentalPatients 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.
Receives: Behavioral: Calorie and protein restriction diet
Control Arm (CA)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight change

    A 7% weight loss

    Measured: Baseline and after 24 months

Secondary outcomes (10)

  1. Metabolic serum biomarkers

    Fasting glucose (mg/dl)

    Measured: Baseline and after 24 months

  2. Metabolic serum biomarkers

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

    Measured: Baseline and after 24 months

  3. Metabolic serum biomarkers

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

    Measured: Baseline and after 24 months

  4. Metabolic serum biomarkers

    Leptin (ng/ml)

    Measured: Baseline and after 24 months

  5. Metabolic serum biomarkers

    Adiponectin (µg/ml)

    Measured: Baseline and after 24 months

  6. Insulin resistance index (HOMA-IR)

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

    Measured: Baseline and after 24 months

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

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

    Measured: Baseline and after 24 months

  8. Esophageal microbiota composition

    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.

    Measured: Baseline and after 24 months

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

    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).

    Measured: Baseline and after 24 months

  10. Waist circumference reduction

    Waist circumference (cm)

    Measured: Baseline and after 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study startNov 2015
  3. Primary completionJun 2021
  4. Study completionDec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03813381
Sponsor's protocol ID
CARE-PRO
Acronym
CARE-PRO
Status last verified
Oct 2023
First submitted
9 Jan 2019
Last updated
16 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Y Lee C. The Effect of High-Fat Diet-Induced Pathophysiological Changes in the Gut on Obesity: What Should be the Ideal Treatment? Clin Transl Gastroenterol. 2013 Jul 11;4(7):e39. doi: 10.1038/ctg.2013.11.

    PubMed 23842483

  • Teng JA, Wu SG, Chen JX, Li Q, Peng F, Zhu Z, Qin J, He ZY. The Activation of ERK1/2 and JNK MAPK Signaling by Insulin/IGF-1 Is Responsible for the Development of Colon Cancer with Type 2 Diabetes Mellitus. PLoS One. 2016 Feb 22;11(2):e0149822. doi: 10.1371/journal.pone.0149822. eCollection 2016.

    PubMed 26901856

  • Zhu N, Zhang Y, Gong YI, He J, Chen X. Metformin and lung cancer risk of patients with type 2 diabetes mellitus: A meta-analysis. Biomed Rep. 2015 Mar;3(2):235-241. doi: 10.3892/br.2015.417. Epub 2015 Jan 9.

    PubMed 26075077

  • Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20.

    PubMed 20647400

  • Vingeliene S, Chan DSM, Vieira AR, Polemiti E, Stevens C, Abar L, Navarro Rosenblatt D, Greenwood DC, Norat T. An update of the WCRF/AICR systematic literature review and meta-analysis on dietary and anthropometric factors and esophageal cancer risk. Ann Oncol. 2017 Oct 1;28(10):2409-2419. doi: 10.1093/annonc/mdx338.

    PubMed 28666313

  • 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.

  • De Ceglie A, Fisher DA, Filiberti R, Blanchi S, Conio M. Barrett's esophagus, esophageal and esophagogastric junction adenocarcinomas: the role of diet. Clin Res Hepatol Gastroenterol. 2011 Jan;35(1):7-16. doi: 10.1016/j.gcb.2010.08.015.

    PubMed 20970272

  • Mayne ST, Navarro SA. Diet, obesity and reflux in the etiology of adenocarcinomas of the esophagus and gastric cardia in humans. J Nutr. 2002 Nov;132(11 Suppl):3467S-3470S. doi: 10.1093/jn/132.11.3467S.

    PubMed 12421872

  • Pera M, Manterola C, Vidal O, Grande L. Epidemiology of esophageal adenocarcinoma. J Surg Oncol. 2005 Dec 1;92(3):151-9. doi: 10.1002/jso.20357.

    PubMed 16299786

  • Vaughan TL, Davis S, Kristal A, Thomas DB. Obesity, alcohol, and tobacco as risk factors for cancers of the esophagus and gastric cardia: adenocarcinoma versus squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 1995 Mar;4(2):85-92.

    PubMed 7742727

  • Shaheen NJ, Richter JE. Barrett's oesophagus. Lancet. 2009 Mar 7;373(9666):850-61. doi: 10.1016/S0140-6736(09)60487-6.

    PubMed 19269522

  • Cameron AJ, Ott BJ, Payne WS. The incidence of adenocarcinoma in columnar-lined (Barrett's) esophagus. N Engl J Med. 1985 Oct 3;313(14):857-9. doi: 10.1056/NEJM198510033131404.

    PubMed 4033716

  • Bhat S, Coleman HG, Yousef F, Johnston BT, McManus DT, Gavin AT, Murray LJ. Risk of malignant progression in Barrett's esophagus patients: results from a large population-based study. J Natl Cancer Inst. 2011 Jul 6;103(13):1049-57. doi: 10.1093/jnci/djr203. Epub 2011 Jun 16.

    PubMed 21680910

  • Hvid-Jensen F, Pedersen L, Drewes AM, Sorensen HT, Funch-Jensen P. Incidence of adenocarcinoma among patients with Barrett's esophagus. N Engl J Med. 2011 Oct 13;365(15):1375-83. doi: 10.1056/NEJMoa1103042.

    PubMed 21995385

  • Runge TM, Abrams JA, Shaheen NJ. Epidemiology of Barrett's Esophagus and Esophageal Adenocarcinoma. Gastroenterol Clin North Am. 2015 Jun;44(2):203-31. doi: 10.1016/j.gtc.2015.02.001. Epub 2015 Apr 9.

    PubMed 26021191

Questions about this trial

What is this clinical trial studying?

A study testing Calorie and protein restriction diet in people with Barrett's Esophagus and Overweight and Obesity, run by Istituto Oncologico Veneto IRCCS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight change (time frame: Baseline and after 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03813381, which also lists 59 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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