Diet ModificationNCT03221920
Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer
A study testing Very Low Carbohydrate Diet in people with Diet Modification and Colorectal Adenocarcinoma, run by Dr. Soetomo General Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diet Modification, Colorectal Adenocarcinoma, Systemic Inflammation
- What is being tested?
- Very Low Carbohydrate Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Patient is still on other therapy for the tumour
- Patient with coexisting diseases which prohibits the patient to follow the study protocols
Trial locations and contacts
No sites are listed yet.
Fransiscus Arifin, MD contact
About this study
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
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
Read the detailed 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.
- Being tested
- Very Low Carbohydrate Diet
- Keywords
- Very Low Carbohydrate Diet, Colorectal Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Carbohydrate DietOther
1 : 4 ratio of carbohydrate to fat of the total daily calories intake
| Study group | Role | What they receive |
|---|---|---|
| Very Low Carbohydrate Diet | Experimental | The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet. Receives: Other: Very Low Carbohydrate Diet |
| Control | No intervention | The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Prognostic Score
A score to evaluate systemic inflammation response
Measured: Change of baseline Glasgow Prognostic Score on day 21
Secondary outcomes (2)
Serum Lactate
Lactate level in blood serum
Measured: Change of baseline Serum Lactate on day 21
TNF Alpha
Level of Tumor Necrosis Factor Alpha in the blood serum
Measured: Change of baseline TNF Alpha serum level on day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start5 Aug 2017 (estimated)
- Primary completion30 Aug 2017 (estimated)
- Study completion30 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vicky S Budipramana, PhD, Principal investigator, RS Dr Sutomo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221920
- Sponsor's protocol ID
- DrSoetomoGH
- Status last verified
- Jul 2017
- First submitted
- 16 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18508572Allen 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.
PubMed 25460731Walenta 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.
PubMed 27557533San-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.
PubMed 27993896Lasry A, Zinger A, Ben-Neriah Y. Inflammatory networks underlying colorectal cancer. Nat Immunol. 2016 Mar;17(3):230-40. doi: 10.1038/ni.3384.
PubMed 26882261Seyfried 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.
PubMed 24343361Venetsanou 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.
PubMed 22042432
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03221920
- Acronym / sponsor ID
- DrSoetomoGH
- Keywords
- Very Low Carbohydrate Diet, Colorectal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 5 Aug 2017 (estimated)
- Primary completion
- 30 Aug 2017 (estimated)
- Study completion
- 30 Aug 2017 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet
| Arm | Type | Receives |
|---|---|---|
| Very Low Carbohydrate Diet | Experimental | Other: Very Low Carbohydrate DietThe 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 . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (2 listed)
- Patient is still on other therapy for the tumour
- Patient with coexisting diseases which prohibits the patient to follow the study protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Low Carbohydrate Diet1 : 4 ratio of carbohydrate to fat of the total daily calories intake | Other | Very Low Carbohydrate Diet |
Primary outcome
Glasgow Prognostic Score
Time frame: Change of baseline Glasgow Prognostic Score on day 21
A score to evaluate systemic inflammation response
2 secondary outcomes
Serum Lactate
Time frame: Change of baseline Serum Lactate on day 21
TNF Alpha
Time frame: Change of baseline TNF Alpha serum level on day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Background: PubMed 18508572Sethi 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.
- Background: PubMed 25460731Allen 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.
- Background: PubMed 27557533Walenta 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.
- Background: PubMed 27993896San-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.
- Background: PubMed 26882261Lasry A, Zinger A, Ben-Neriah Y. Inflammatory networks underlying colorectal cancer. Nat Immunol. 2016 Mar;17(3):230-40. doi: 10.1038/ni.3384.
- Background: PubMed 24343361Seyfried 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.
- Background: PubMed 22042432Venetsanou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fransiscus Arifin, MD contact
Vicky S Budipramana, PhD principal investigator
RS Dr Sutomo
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Carbohydrate Diet in people with Diet Modification and Colorectal Adenocarcinoma, run by Dr. Soetomo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicky S Budipramana, PhD (0811315812, vickysbudi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Prognostic Score (time frame: Change of baseline Glasgow Prognostic Score on day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03221920, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.