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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046647
Receipt No. R000053210
Scientific Title A prospective study to evaluate the feasibility and usefulness of a smartphone site aimed at improving taste disorders and nutritional status in cancer patients undergoing chemotherapy
Date of disclosure of the study information 2022/01/17
Last modified on 2022/01/15

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Basic information
Public title A prospective study to evaluate the feasibility and usefulness of a smartphone site aimed
at improving taste disorders and nutritional status in cancer patients undergoing chemotherapy
Acronym OISHY Study
Scientific Title A prospective study to evaluate the feasibility and usefulness of a smartphone site aimed
at improving taste disorders and nutritional status in cancer patients undergoing chemotherapy
Scientific Title:Acronym OISHY Study
Region
Japan

Condition
Condition Gastrointestinal caner, Head and neck cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examine whether dietary support for cancer chemotherapy patients can be provided using the Internet, and whether it will improve patient outcomes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Step1 (30 patients): Percentage of patients who completed 9 weeks of input
Step2 (200 people): Weight loss rate of 3% or more before and after the start of treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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 Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Nutritional intervention using smartphone site
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed as gastrointestinal cancer / head and neck cancer.
2) We plan to start a new regimen of palliative chemotherapy including cell-killing drugs or preoperative chemotherapy for gastrointestinal / head and neck cancer.
3) Over 20 years old.
4) It can be taken orally.
5) Performance status (PS) 0-2.
6) It does not matter if there is an evaluable lesion.
7) I can understand Japanese.
8) You can continue to input to the smartphone site.
9) The patient himself has given written consent to participate in the study.
Key exclusion criteria 1) Be aware of obvious dysgeusia before starting treatment.
2) Radiation therapy that includes the gastrointestinal tract in the irradiation field will be used in combination.
3) Medical professionals have determined that it is difficult to participate in this study.
Target sample size 230

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Kato
Organization National Cancer Center Hospital
Division name Department of Head and Neck, Esophageal Medical Oncology / Department of Gastrointestinal Medical Oncology
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email kenkato@ncc.go.jp

Public contact
Name of contact person
1st name Ken
Middle name
Last name Kato
Organization National Cancer Center Hospital
Division name Department of Head and Neck, Esophageal Medical Oncology / Department of Gastrointestinal Medical O
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email kenkato@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital,
Institute
Department

Funding Source
Organization Oishi kenko Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel 03-3547-5201
Email irst@ml.res.ncc.go.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
2022 Year 01 Month 17 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
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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
2020 Year 12 Month 22 Day
Anticipated trial start date
2020 Year 12 Month 28 Day
Last follow-up date
2023 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 15 Day
Last modified on
2022 Year 01 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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