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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care

Conditions
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TNF Alpha, Diet Modification, Colorectal Adenocarcinoma, Systemic Inflammation, Lactate

Intervention / Treatment
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* Other: Very Low Carbohydrate Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very Low Carbohydrate Diet<br>The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet. | Other: Very Low Carbohydrate Diet<br>* 1 : 4 ratio of carbohydrate to fat of the total daily calories intake<br>|
| No Intervention: Control<br>The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Prognostic Score | A score to evaluate systemic inflammation response | Change of baseline Glasgow Prognostic Score on day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lactate | Lactate level in blood serum | Change of baseline Serum Lactate on day 21 | 
| TNF Alpha | Level of Tumor Necrosis Factor Alpha in the blood serum | Change of baseline TNF Alpha serum level on day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Very Low Carbohydrate Diet, Colorectal Adenocarcinoma