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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044132
Receipt No. R000050395
Scientific Title Study on the safety of modified MCT ketogenic diet and standard therapy combination therapy for colorectal cancer patients
Date of disclosure of the study information 2021/05/08
Last modified on 2021/05/07

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Basic information
Public title Study on the safety of modified MCT ketogenic diet and standard therapy combination therapy for colorectal cancer patients
Acronym Study on MCT ketogenic diet for colorectal cancer patients
Scientific Title Study on the safety of modified MCT ketogenic diet and standard therapy combination therapy for colorectal cancer patients
Scientific Title:Acronym Study on MCT ketogenic diet for colorectal cancer patients
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety of the modified MCT ketogenic diet as a combination therapy in patients who perform the current standard treatment for colorectal cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Safety
Presence or absence of diarrhea or allergic symptoms
b. Dehydration, symptomatological hypoglycemia, excessive ketosis, gastrointestinal symptoms
Nutritional status (body weight, body composition analysis using In Body (BIA), serum albumin, serum cholinesterase, serum transthyretin, CRP), QOL score (EORTCQLQ-CR38 Japanese version, POMS2 Japanese version)
Key secondary outcomes Response rate, pathological control rate, surgical transition rate, transition of tumor markers (including serum anti-p53 antibody titer), PET scan in the clinical range, blood glucose and ketone body measurement using FreeStyle Libre outside the hospital for those who wish Give guidance. In addition, for possible cases, serum and urinary ketone bodies and urinary 8-OHdG will be measured.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Nutrition counseling
We provide outpatient nutritional guidance once a month for 30 minutes. It can be calculated once a month as an outpatient nutrition dietary guidance fee.
The modified MCT ketogenic diet is 2-3 meals a day, prepared under the supervision of a registered dietitian, and you can cook your own food according to the following rules, or obtain low-carbohydrate foods at the supermarket or the Internet. .. Meal purchase funds will be borne by the patient. Cooking recipes will be distributed at the start of clinical research.
7 rules of dietary intake
1. The target energy intake is 35-40 kcal per body weight.
2. Eat 1.6-2.0 g of protein-rich foods (meat, fish, eggs, soy products) per body weight.
3. Take at least 4g of EPA daily.
4. Limit the amount of sugar to 25 g or less per day (when the body weight is 50 kg).
5. Ingest 60 to 100 g of medium-chain fatty acids per day in terms of MCT oil.
6. The weight of the meal is morning: noon: evening = 4: 10: 6, and the weight is adjusted so that the person feels hungry before going to bed.
7. The target ketone ratio is 1.4 to 1.6: 1.

Estimated implementation period and meal contents (see A and B below)
1. First 3 months: Super ketogenic.
2. From 3 months to 1 year: Continue to eat ketogenic diet, mainly super ketogenic.
3. After the above research period is exceeded, we will instruct them to continue ketogenic and semi-ketogenic
Level of carbohydrate restriction
1. Semi-ketogenic
Ketone ratio Lipid: Sugar + Protein = 1: 1
Sugar intake 80 g / day or less
Lipid intake: flaxseed oil 30 g / day, MCT oil 80 mg / day (total fat 110 g)
2. Ketogenic
Ketone ratio Lipid: Sugar + Protein = 1.4: 1
Sugar intake 40 g / day or less
Lipid intake: flaxseed oil 30 g / day, MCT oil 80 mg / day (total fat 110 g)
3. Super ketogenic
Ketone ratio Lipid: Sugar + Protein = 1.6: 1
Sugar intake 20 g / day or less
Lipid intake: flaxseed oil 30 g / day, MCT oil 100 mg / day (total fat 130 g)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases of standard treatment according to the breast cancer clinical practice guidelines published by the Japan Breast Cancer Society
Key exclusion criteria 1. Weight loss of 5% or more has been observed in the last 3 months.
2. Highly advanced example
(Exclusion example) When there is liver metastasis, deterioration of liver function, jaundice, and ascites.
(Exclusion example) When there is lung metastasis and there are clinical symptoms such as pleural effusion and respiratory distress.
However, bone metastases and brain metastases are not excluded.
3. If you have a history of ileus or peritoneal dissemination.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naohiro
Middle name
Last name Washizawa
Organization Toho University Omori Medical Center
Division name Nutrition Therapy Center
Zip code 1438541
Address Omori-Nishi 6-11-1, Ota-Ku, Tokyo
TEL 0337624151
Email washi@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Naohiro
Middle name
Last name Washizawa
Organization Nutrition Therapy Center
Division name Nutrition Therapy Center
Zip code 1438541
Address Omori-Nishi 6-11-1, Ota-Ku, Tokyo
TEL 0337624151
Homepage URL
Email washi@med.toho-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center, Department of Nutrition Therapy Center
Institute
Department

Funding Source
Organization Toho University Faculty of Medicine, Department of Clinical Support Section
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toho University Omori Medical Center
Address Omori-Nishi 6-11-1, Ota-Ku, Tokyo
Tel 0337624151
Email saki.nakagawa@ext.toho-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2021 Year 05 Month 12 Day
Date of IRB
2019 Year 11 Month 08 Day
Anticipated trial start date
2021 Year 05 Month 13 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 07 Day
Last modified on
2021 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050395

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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