NCT03221920 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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. Review.
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. Review.
San-Millán 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.
Sethi G, Sung B, Aggarwal BB
TNF: a master switch for inflammation to cancer. Front Biosci. 2008 May 1;13:5094-107. Review.
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. Review.
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.
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. Review.

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

Clinical trial NCT03221920 - References