UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029527 |
|---|---|
| Receipt number | R000033738 |
| Scientific Title | Study on QOL improvement with the glucide diet which enhanced protein and EPA in advanced colorectal cancer and breast cancer for stage IV |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2017/12/06 19:41:14 |
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Basic information
Public title
Study on QOL improvement with the glucide diet which enhanced protein and EPA in advanced colorectal cancer and breast cancer for stage IV
Acronym
Study of the glucide diet for the advanced cancer
Scientific Title
Study on QOL improvement with the glucide diet which enhanced protein and EPA in advanced colorectal cancer and breast cancer for stage IV
Scientific Title:Acronym
Study of the glucide diet for the advanced cancer
Region
| Japan |
Condition
Condition
colorectal cancer, breast cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The patient takes in the glucide diet which enhanced protein and EPA at home without changing a total calorie for three month. We examine tumor marker, the size of tumor, the change of the nourishment state. In outpatient department, I perform blood sugar, blood ketone body, a blood examination, a medical examination, and we evaluate the QOL every month in EORTC QLQ-C30.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The evaluation is every month after a glucide diet start.
Blood sugar level, blood ketone body density, the weight, albumin level, renal function (BUN, Cr), liver function (GOT, GPT), QOL score)
Key secondary outcomes
The evaluation is three month after a glucide diet start.
The RECIST evaluation by the examination for CT. Change of the 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
An intervention period: The glucide diet is three months by every meal.
A daily glucide intake: Less than 5% of intake energy.
Daily EPA(eicosapentaenoic acid) intake: More than 2 g.
A daily protein intake: More than weight * 1.6g.
A daily middle chain fatty acid intake: More than 40 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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Advanced colorectal cancer and breast cancer patient of stage IV when standard treatment was not effective.
The combination of chemotherapy and the radiation therapy is possible.
1.Cancer with the insurance adaptation of the PET-CT examination.
2.Performance status is 2 from 0.
3.The function of organs is normal, and there is not impaired glucose tolerance.
4.In past three months, a weight loss is less than 5%.
5.BMI(Body mass index) is more than 18 kg/m2.
Key exclusion criteria
Diabetic patient
Cachexy patient
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo katuragawa |
Organization
Tama-Nanbu Regional Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation
Division name
Department of Surgery
Zip code
Address
2-1-2 nakazawa Tama-city Tokyo
TEL
042-338-5111
hideo_katuragawa@tokyo-hmt.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Furukawa |
Organization
Tama-Nanbu regional Hospital
Division name
Department of Surgery
Zip code
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
No
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
（公財）東京都保健医療公社 多摩南部地域病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A 3-month combination of the modified MCT ketogenic diet and chemotherapy was safe for stage IV cancer patients and allowed them to maintain quality of life. We believe that tumor reduction was associated with blood ketone body level.
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
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2017 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033738
