UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020875
Receipt number R000024087
Scientific Title Randomized clinical trial concerning diet for outpatients treated with chemotherapy in Hematology /Clinical Oncology division
Date of disclosure of the study information 2016/02/04
Last modified on 2024/02/13 12:26:08

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Basic information

Public title

Randomized clinical trial concerning diet for outpatients treated with chemotherapy in Hematology /Clinical Oncology division

Acronym

Diet Trial for Hematological Malignacies

Scientific Title

Randomized clinical trial concerning diet for outpatients treated with chemotherapy in Hematology /Clinical Oncology division

Scientific Title:Acronym

Diet Trial for Hematological Malignacies

Region

Japan


Condition

Condition

Malignant lymphoma
Multiple myeloma
Myelodysplastic syndrome
Chronic lymphatic leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To prove that the outcome of the patients who can eat anything without any restriction is equal to that of the patients whose diet is restricted to heated-food

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

The incidence of infection of Grade 3 or more in the first three cycles

Key secondary outcomes


In the first three cycles,thefollowing are to be evaluated as secondary outcoms:1) the incidence of infection of Grade3 ormore with the obvious focus and with neutropenia, 2)the incidence of infection of Grade3 or more without neutropenia, 3) the incidence of febrile neutropenia of Grade3 or more, 4) the rate of discontinuation of treatment due to infection, 5) the rate of postponement of traetment, 6) the difference in the patients' satisfaction between the two diet groups, and 7) the difference in the nutrition state between the two diet groups.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The group of the patients who have diet to be restricted only to heated food up to the end of the first three cycles

Interventions/Control_2

The group of the patients who can eat anything without any restriction in the first cycles

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who are diagnosed as having malignant lymphoma, multiple myeloma, myelodysplastic syndrome,
or chronic lymphocytic lymphoma,
who will be treated with chemotherapy as outpatients at least in one cycle among the first three cycles

Key exclusion criteria

none

Target sample size

440


Research contact person

Name of lead principal investigator

1st name Mami
Middle name
Last name Mizoguchi

Organization

Komaki City Hospital

Division name

Regional Cooperation Division

Zip code

485-8520

Address

Jobushi 1-20, Komaki , Aichi Prefecture

TEL

0568-76-4131

Email

Renkei@city.komaki.lg.jp


Public contact

Name of contact person

1st name Mami
Middle name
Last name Mizoguchi

Organization

Komaki City Hospital

Division name

Regional Cooperation Division

Zip code

485-8520

Address

Jobushi 1-20, Komaki , Aichi Prefecture

TEL

0568-76-4131

Homepage URL


Email

Renkei@city.komaki.lg.jp


Sponsor or person

Institute

Komaki City Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Komaki City Hospital IRB

Address

Jobushi 1-20,Komaki,Aichi Prefecture

Tel

0568-76-4131

Email

kch-gen@komakihp.gr.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

小牧市民病院 Komaki City Hospital; and so on.


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 04 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


Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Exam suspended

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

Suspended

Date of protocol fixation

2015 Year 09 Month 01 Day

Date of IRB

2015 Year 09 Month 01 Day

Anticipated trial start date

2015 Year 09 Month 14 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 04 Day

Last modified on

2024 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024087


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name