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

NCT ID: NCT03221920

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-05
• Study Completion Date: 2017-08-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Very Low Carbohydrate Diet

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

Group Type: EXPERIMENTAL

Very Low Carbohydrate Diet

Intervention Type: OTHER

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Very Low Carbohydrate Diet

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Soetomo General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vicky S Budipramana, PhD

Role: PRINCIPAL_INVESTIGATOR

RS Dr Sutomo

Central Contacts

Vicky S Budipramana, PhD

Role: CONTACT

vickysbudi@gmail.com

0811315812

Fransiscus Arifin, MD

Role: CONTACT

farifin@gmail.com

References

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Reference Type: BACKGROUND

PMID: 18508572 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25460731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27557533 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27993896 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26882261 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24343361 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22042432 (View on PubMed)

Other Identifiers

DrSoetomoGH

Identifier Type: -

Identifier Source: org_study_id