Diet Modification, Colorectal Adenocarcinoma, Systemic Inflammation, TNF Alpha, Lactate
Conditions
Keywords
Very Low Carbohydrate Diet, Colorectal Adenocarcinoma
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.
Interventions
1 : 4 ratio of carbohydrate to fat of the total daily calories intake
Sponsors
Dr. Soetomo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
Care provider are not told whether the patient belongs to intervention or control group
Intervention model description
Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Prognostic Score | Change of baseline Glasgow Prognostic Score on day 21 | A score to evaluate systemic inflammation response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactVicky S Budipramana, PhD
Backup ContactFransiscus Arifin, MD
Outcome results
None listed