UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Acronym	A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Scientific Title	A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Scientific Title:Acronym	A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examination of the effect of the intervention for diet satisfaction for taste alteration associated with the chemotherapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The satisfaction level of the diet by the taste alteration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The support by the nurse using the brochure about the taste alteration
Interventions/Control_2	Usually support care by the nurse
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	Female
Key inclusion criteria	1.The women who were diagnosed as breast cancer newly. 2.20 years of age or over. 3.The patients who receive chemotherapy ( anthracyclines and taxanes)before or after operation. 4.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 5.The patients who do not have taste alteration and oral complication or dysphagia. 6.The patients who agree with the study and do not have communication disorder.
Key exclusion criteria	1.The patients stage 4 with advanced breast cancer or the patients recurrent with breast cancer. 2.The patients who received chemotherapy previously because of cancer treatment. 3.The patients who received radiotherapy to oral cavity or salivary gland previously. 4.The patients who had operation to oral cavity previously. 5.The patients who take a medicine which contains zinc currently or previously because of taste alteration. 6.The patients with serious renal disease(more than serum Cr 2.0mg/dL), or receive dialysis. 7.The patients with serious liver disease. 8.The patients with hepatic disorder, mental disorder, an oral cavity malignant tumor and the diabetes. 9.The patients who have already taken a supplement which contains zinc or a medicine which contains zinc. 10.Patients who are excluded by the doctor&#39;s judgment.
Target sample size	150

Research contact person
Last name of lead principal investigator	1st name Kazuaki Middle name Last name Tanabe
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Department of Health Care for Adults
Zip code	734-8553
Address	1-2-3 Kasumi, Minamiku-ku, Hiroshima City, Hiroshima prefecture
TEL	082-257-5383
Email	ktanae2@hiroshima-u.ac.jp

Public contact
1st name of contact person	1st name Sanae Middle name Last name Asano
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Department of Health Care for Adults
Zip code	734-8553
Address	1-2-3 Kasumi, Minamiku-ku, Hiroshima City, Hiroshima prefecture
TEL	082-257-5383
Homepage URL
Email	asano-sanae@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Graduate School of Biomedical & Health Sciences
Institute
Department

Funding Source
Organization	YAMAJI FUMIKO NURSING RESERACH FUND
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	Hiroshima Univercity Hospital
Address	1-2-3 Kasumi, Minamiku-ku, Hiroshima City, Hiroshima prefecture
Tel	082-257-5907
Email	kasumi-kenkyu@office.hiroshima-u.ac.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	2014 Year 10 Month 21 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	88
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 09 Month 17 Day
Date of IRB
Anticipated trial start date	2014 Year 10 Month 24 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 20 Day
Last modified on	2019 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017478