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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Carbohydrate Diet | Experimental | 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 . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Low Carbohydrate Diet | Other | 1 : 4 ratio of carbohydrate to fat of the total daily calories intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Prognostic Score | A score to evaluate systemic inflammation response | Change of baseline Glasgow Prognostic Score on day 21 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicky S Budipramana, PhD | Contact | 0811315812 | vickysbudi@gmail.com | |
| Fransiscus Arifin, MD | Contact | farifin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vicky S Budipramana, PhD | RS Dr Sutomo | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18508572 | Background | Sethi G, Sung B, Aggarwal BB. TNF: a master switch for inflammation to cancer. Front Biosci. 2008 May 1;13:5094-107. doi: 10.2741/3066. | |
| 25460731 | Background | 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. |
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Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet
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Care provider are not told whether the patient belongs to intervention or control group
| Change of baseline TNF Alpha serum level on day 21 |
| 27557533 | Background | 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. |
| 27993896 | Background | 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. |
| 26882261 | Background | 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. |
| 24343361 | Background | 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. |
| 22042432 | Background | 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. |