UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044132 |
|---|---|
| Receipt number | 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 14:15:51 |
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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
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
washi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center, Department of Nutrition Therapy Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050395
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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