UMIN-CTR Clinical Trial

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