Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer

Diet Modification Clinical Trial

Official title:

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03221920
• Other study ID #: DrSoetomoGH
• Status: Not yet recruiting
• Phase: N/A
• First received: July 16, 2017
• Last updated: July 28, 2017
• Start date: August 5, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: July 2017
• Source: Dr. Soetomo General Hospital
• Contact: Vicky S Budipramana, PhD
• Phone: 0811315812
• Email: vickysbudi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma
• Colorectal Neoplasms
• Diet Modification
• Inflammation
• Lactate
• Systemic Inflammation
• TNF Alpha

Intervention

Other:
• Very Low Carbohydrate Diet
1 : 4 ratio of carbohydrate to fat of the total daily calories intake

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Soetomo General Hospital

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Prognostic Score	A score to evaluate systemic inflammation response	Change of baseline Glasgow Prognostic Score on day 21
Secondary	Serum Lactate	Lactate level in blood serum	Change of baseline Serum Lactate on day 21
Secondary	TNF Alpha	Level of Tumor Necrosis Factor Alpha in the blood serum	Change of baseline TNF Alpha serum level on day 21