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Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer

Primary Purpose

Diet Modification, Colorectal Adenocarcinoma, Systemic Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Very Low Carbohydrate Diet
Sponsored by
Dr. Soetomo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diet Modification focused on measuring Very Low Carbohydrate Diet, Colorectal Adenocarcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed as colorectal adenocarcinoma pathologically
  • Decided by a digestive surgery consultant to be managed with best supportive care
  • More than 17 years old and capable of making informed consent
  • Karnofsky score > 50% or ECOG performance status <=2
  • No clinical signs of infection, with one or more of these criteria : fever, leukocytosis, local sign of infection (eg.abscess,ulcer)
  • AST < 2 times normal limit
  • ALT < 2 times normal limit
  • Serum Creatinine < 1,5 times normal limit
  • Not pregnant (for women)
  • Able to understand and willing participate and to sign informed consent form
  • No Diabetes Mellitus
  • No fat intolerance
  • No severe malnutrition or cancer cachexia

Exclusion Criteria:

  • Patient is still on other therapy for the tumour
  • Patient with coexisting diseases which prohibits the patient to follow the study protocols

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Very Low Carbohydrate Diet

    Control

    Arm Description

    The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.

    The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy .

    Outcomes

    Primary Outcome Measures

    Glasgow Prognostic Score
    A score to evaluate systemic inflammation response

    Secondary Outcome Measures

    Serum Lactate
    Lactate level in blood serum
    TNF Alpha
    Level of Tumor Necrosis Factor Alpha in the blood serum

    Full Information

    First Posted
    July 16, 2017
    Last Updated
    July 28, 2017
    Sponsor
    Dr. Soetomo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03221920
    Brief Title
    Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer
    Official Title
    Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 5, 2017 (Anticipated)
    Primary Completion Date
    August 30, 2017 (Anticipated)
    Study Completion Date
    August 30, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dr. Soetomo General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels
    Detailed Description
    This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels. The subjects are colorectal adenocarcinoma patients who were decided by experts to be managed by best supportive care. These patients are not deemed to be suitable for surgical intervention , chemotherapy or radiotherapy anymore. The main treatment is supportive. We would like to examined the effect of very low carbohydrate diet on these patients, in which theoretically tumtor cells of the colorectal adenocarcinoma needed glucose to replicate and increases the systemic inflammation response.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diet Modification, Colorectal Adenocarcinoma, Systemic Inflammation, TNF Alpha, Lactate
    Keywords
    Very Low Carbohydrate Diet, Colorectal Adenocarcinoma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet
    Masking
    Care Provider
    Masking Description
    Care provider are not told whether the patient belongs to intervention or control group
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Very Low Carbohydrate Diet
    Arm Type
    Experimental
    Arm Description
    The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy .
    Intervention Type
    Other
    Intervention Name(s)
    Very Low Carbohydrate Diet
    Intervention Description
    1 : 4 ratio of carbohydrate to fat of the total daily calories intake
    Primary Outcome Measure Information:
    Title
    Glasgow Prognostic Score
    Description
    A score to evaluate systemic inflammation response
    Time Frame
    Change of baseline Glasgow Prognostic Score on day 21
    Secondary Outcome Measure Information:
    Title
    Serum Lactate
    Description
    Lactate level in blood serum
    Time Frame
    Change of baseline Serum Lactate on day 21
    Title
    TNF Alpha
    Description
    Level of Tumor Necrosis Factor Alpha in the blood serum
    Time Frame
    Change of baseline TNF Alpha serum level on day 21

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as colorectal adenocarcinoma pathologically Decided by a digestive surgery consultant to be managed with best supportive care More than 17 years old and capable of making informed consent Karnofsky score > 50% or ECOG performance status <=2 No clinical signs of infection, with one or more of these criteria : fever, leukocytosis, local sign of infection (eg.abscess,ulcer) AST < 2 times normal limit ALT < 2 times normal limit Serum Creatinine < 1,5 times normal limit Not pregnant (for women) Able to understand and willing participate and to sign informed consent form No Diabetes Mellitus No fat intolerance No severe malnutrition or cancer cachexia Exclusion Criteria: Patient is still on other therapy for the tumour Patient with coexisting diseases which prohibits the patient to follow the study protocols
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vicky S Budipramana, PhD
    Phone
    0811315812
    Email
    vickysbudi@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fransiscus Arifin, MD
    Email
    farifin@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vicky S Budipramana, PhD
    Organizational Affiliation
    RS Dr Sutomo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    18508572
    Citation
    Sethi G, Sung B, Aggarwal BB. TNF: a master switch for inflammation to cancer. Front Biosci. 2008 May 1;13:5094-107. doi: 10.2741/3066.
    Results Reference
    background
    PubMed Identifier
    25460731
    Citation
    Allen BG, Bhatia SK, Anderson CM, Eichenberger-Gilmore JM, Sibenaller ZA, Mapuskar KA, Schoenfeld JD, Buatti JM, Spitz DR, Fath MA. Ketogenic diets as an adjuvant cancer therapy: History and potential mechanism. Redox Biol. 2014;2:963-70. doi: 10.1016/j.redox.2014.08.002. Epub 2014 Aug 7.
    Results Reference
    background
    PubMed Identifier
    27557533
    Citation
    Walenta S, Voelxen NF, Mueller-Klieser W. Lactate-An Integrative Mirror of Cancer Metabolism. Recent Results Cancer Res. 2016;207:23-37. doi: 10.1007/978-3-319-42118-6_2.
    Results Reference
    background
    PubMed Identifier
    27993896
    Citation
    San-Millan I, Brooks GA. Reexamining cancer metabolism: lactate production for carcinogenesis could be the purpose and explanation of the Warburg Effect. Carcinogenesis. 2017 Feb 1;38(2):119-133. doi: 10.1093/carcin/bgw127.
    Results Reference
    background
    PubMed Identifier
    26882261
    Citation
    Lasry A, Zinger A, Ben-Neriah Y. Inflammatory networks underlying colorectal cancer. Nat Immunol. 2016 Mar;17(3):230-40. doi: 10.1038/ni.3384.
    Results Reference
    background
    PubMed Identifier
    24343361
    Citation
    Seyfried TN, Flores RE, Poff AM, D'Agostino DP. Cancer as a metabolic disease: implications for novel therapeutics. Carcinogenesis. 2014 Mar;35(3):515-27. doi: 10.1093/carcin/bgt480. Epub 2013 Dec 16.
    Results Reference
    background
    PubMed Identifier
    22042432
    Citation
    Venetsanou K, Kaldis V, Kouzanidis N, Papazacharias Ch, Paraskevopoulos J, Baltopoulos G. Measurement of tumour necrosis factor receptors for immune response in colon cancer patients. Clin Exp Med. 2012 Dec;12(4):225-31. doi: 10.1007/s10238-011-0162-5. Epub 2011 Nov 1.
    Results Reference
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    Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer

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