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

Not Applicable

• Conditions: Lactate; Diet Modification; Colorectal Adenocarcinoma; Systemic Inflammation; TNF Alpha
• Interventions: Other: Very Low Carbohydrate Diet

• Registration Number: NCT03221920
• Lead Sponsor: Dr. Soetomo General Hospital

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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-16
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01
• Study Start: 2017-08-05
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very Low Carbohydrate Diet	Very Low Carbohydrate Diet	The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.

Primary Outcome Measures

Name	Time	Method
Glasgow Prognostic Score	Change of baseline Glasgow Prognostic Score on day 21	A score to evaluate systemic inflammation response

Secondary Outcome Measures

Name	Time	Method
Serum Lactate	Change of baseline Serum Lactate on day 21	Lactate level in blood serum
TNF Alpha	Change of baseline TNF Alpha serum level on day 21	Level of Tumor Necrosis Factor Alpha in the blood serum