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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039925
Receipt No. R000045527
Scientific Title Study on the safety and efficacy of the ketogenic diets for stage IV advanced and recurrent cancer patients.
Date of disclosure of the study information 2020/03/31
Last modified on 2020/03/24

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Basic information
Public title Study on the safety and efficacy of the ketogenic diets for stage IV advanced and recurrent cancer patients.
Acronym KDAC study
Scientific Title Study on the safety and efficacy of the ketogenic diets for stage IV advanced and recurrent cancer patients.
Scientific Title:Acronym KDAC study
Region
Japan

Condition
Condition All types of cancer for which PET-CT examination is indicated
Classification by specialty
Endocrinology and Metabolism Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Subjects were cancers eligible for PET-CT examination. In addition, the time to introduce the ketogenic diets will be after the stage IV diagnosis, and safety and effectiveness will be reconfirmed. Patients make a ketogenic diets at home, and we will examine changes in tumor markers, changes in tumor size, and changes in nutritional status. Every month, outpatient or hospitalized, blood sugar, blood ketones, blood count and biochemical tests, and RECIST evaluation by CT and MRI once every three months.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Evaluated every 3 months after starting ketogenic diets
RECIST assessment by CT or MRI.
Key secondary outcomes Monthly evaluation after starting ketone meal
Changes in blood sugar level, blood ketone body level, body weight, plasma albumin level, renal function (BUN, Cr), liver function (GOT, GPT), tumor marker.

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intervention period: 1 year
The criteria for a ketogenic diet are as follows:
Daily carbohydrate intake: 5% or less of energy intake
Daily EPA intake: 2g or more
Daily protein intake: Weight x 1.6g or more
Daily chain fatty acid intake: 40g or more
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Stage IV advanced/recurrent cancer patients who meet the following conditions (1 to 4 are essential conditions) However, combined use of anticancer drugs and radiation therapy is essential.
1. Cancers for which PET-CT is indicated
2. Eastern Cooperative Oncology Group standard performance status (PS) 0-2
3. Various organ functions are normal.
4. No weight loss in the last 3 months (less than 5%)
5. BMI is over 18kg/m2
Key exclusion criteria Cachexia patients
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hideo
Middle name
Last name Katsuragawa
Organization Tama-Nanbu Regional Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation
Division name Department of Surgery
Zip code 206-0036
Address 2-1-2 nakazawa Tama-city Tokyo
TEL 042-338-5111
Email hideo_katsuragawa@tokyo-hmt.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Furukawa
Organization Tama-Nanbu Regional Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation
Division name Department of Surgery
Zip code 206-0036
Address 2-1-2 nakazawa Tama-city Tokyo
TEL 042-338-5111
Homepage URL
Email kenji_furukawa@tokyo-hmt.jp

Sponsor
Institute Tama-Nanbu Regional Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation
Department of Surgery
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tama-Nanbu Regional Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation
Address 2-1-2 nakazawa Tama-city Tokyo
Tel 042-338-5111
Email kenji_furukawa@tokyo-hmt.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
2020 Year 03 Month 31 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 30
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 Completed
Date of protocol fixation
2014 Year 12 Month 19 Day
Date of IRB
2018 Year 09 Month 20 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 03 Month 24 Day
Last modified on
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045527

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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