Clinical trial · Interventional
Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer
Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care
NCT03221920CI-TRIAL-00028878unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Diet Modification | — | UNRESOLVED | — |
| Lactate | — | UNRESOLVED | — |
| Systemic Inflammation | — | UNRESOLVED | — |
| TNF Alpha | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Very Low Carbohydrate Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Very Low Carbohydrate Diet
- description
- The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.
- interventionNames
- Other: Very Low Carbohydrate Diet
- type
- NO_INTERVENTION
- label
- Control
- description
- The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy .
Primary outcomes (1)
- measure
- Glasgow Prognostic Score
- timeFrame
- Change of baseline Glasgow Prognostic Score on day 21
- description
- A score to evaluate systemic inflammation response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDSethi 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. PMID 18508572
- BACKGROUNDAllen 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. PMID 25460731
- BACKGROUNDWalenta 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. PMID 27557533
- BACKGROUNDSan-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. PMID 27993896
- BACKGROUNDLasry A, Zinger A, Ben-Neriah Y. Inflammatory networks underlying colorectal cancer. Nat Immunol. 2016 Mar;17(3):230-40. doi: 10.1038/ni.3384. PMID 26882261
- BACKGROUNDSeyfried 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. PMID 24343361
- BACKGROUNDVenetsanou 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. PMID 22042432