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

NCT03221920 | Unknown

• 1 other identifier: DrSoetomoGH
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diet Modification; Colorectal Adenocarcinoma; Systemic Inflammation; TNF Alpha; Lactate

Keywords

Very Low Carbohydrate Diet; Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Glasgow Prognostic Score

  A score to evaluate systemic inflammation response

  Change of baseline Glasgow Prognostic Score on day 21

Secondary Outcomes (2)

• Serum Lactate

  Change of baseline Serum Lactate on day 21

• TNF Alpha

  Change of baseline TNF Alpha serum level on day 21

Study Arms (2)

Very Low Carbohydrate Diet

EXPERIMENTAL

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

Other: Very Low Carbohydrate Diet

Control

NO INTERVENTION

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

Interventions

Very Low Carbohydrate Diet OTHER

1 : 4 ratio of carbohydrate to fat of the total daily calories intake

Very Low Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead

Related Publications (7)

• 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.

  PMID: 18508572 BACKGROUND

• 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.

  PMID: 25460731 BACKGROUND

• 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.

  PMID: 27557533 BACKGROUND

• 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.

  PMID: 27993896 BACKGROUND

• 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.

  PMID: 26882261 BACKGROUND

• 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.

  PMID: 24343361 BACKGROUND

• 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.

  PMID: 22042432 BACKGROUND

Study Officials

• Vicky S Budipramana, PhD

  RS Dr Sutomo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicky S Budipramana, PhD

CONTACT

0811315812; vickysbudi@gmail.com

Fransiscus Arifin, MD

CONTACT

farifin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider are not told whether the patient belongs to intervention or control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 19, 2017
• Study Start: August 5, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07