UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039925
Receipt number 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 23:23:07

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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