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
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
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
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
