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

Dr. Soetomo General Hospital

Status: Unknown

Conditions: Systemic Inflammation; Colorectal Adenocarcinoma; Lactate; TNF Alpha; Diet Modification

Treatments: Other: Very Low Carbohydrate Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03221920

DrSoetomoGH

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

26 participants in 2 patient groups

Very Low Carbohydrate Diet

Experimental group

Description:

The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.

Treatment:

Other: Very Low Carbohydrate Diet

Control

No Intervention group

Description:

The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy .