Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care
| Registry | NCT03221920 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 26 (Estimated) |
| Sponsor | Dr. Soetomo General Hospital (Other gov) |
| Conditions | Diet Modification, Colorectal Adenocarcinoma, Systemic Inflammation, TNF Alpha, Lactate |
| Interventions | Very Low Carbohydrate Diet (Other) |
| Dates | start 2017-08-05 (estimated), primary completion 2017-08-30 (estimated), completion 2017-08-30 (estimated), first posted 2017-07-19, last updated 2017-08-01 |
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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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Very Low Carbohydrate Diet | Experimental | Other: Very Low Carbohydrate Diet | The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet. |
| Control | No intervention | The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy . |
Sex: All, ages: 18 Years to 65 Years
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