UMIN-CTR Clinical Trial

Basic information
Public title	Acupressure for Nausea and Vomiting in end of life cancer patients:Pilot Study
Acronym	Acupressure for Nausea and Vomiting in end of life cancer patients:Pilot Study
Scientific Title	Acupressure for Nausea and Vomiting in end of life cancer patients:Pilot Study
Scientific Title:Acronym	Acupressure for Nausea and Vomiting in end of life cancer patients:Pilot Study
Region	Japan

Condition
Condition	Patients receiving palliative care
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To consider acupressure effects on nausea and vomiting in palliative care.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Changes in the average of nausea NRS (before and 30 minutes after intervention)
Key secondary outcomes	Adverse event Decrease in the nausea NRS value (before-15 minutes after intervention, 15 minutes-30 minutes after intervention) The degree of nausea NRS by the time zone (morning, afternoon) in which acupressure carried out

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	acupressure
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	99 years-old >
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with cancer. Patients over twenty years of age. Patients who have been hospitalized in the palliative care unit during the research period. Patients who can communicate. Patients who have nausea before the start of intervention. Patients who agrees to participate in the research.
Key exclusion criteria	Patients who are undergoing chemotherapy. Patients who are undergoing radiotherapy for therapeutic purpose. Patients who have experience in acupressure of Neiguan and Zusanli. Consider the patient's prognosis and not match a research object. Patients who have history of Bradycardia,sick sinus syndrome,atrioventricular block and bradycardia atrial fibrillation. Patients who have severe mental symptoms and the research cooperation is difficult. If the researcher consider it inappropriate to participate in the survey.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitsunori Miyashita
Organization	Tohoku University School of Medicine
Division name	Department of Palliative Nursing, Health Science
Zip code
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Mayagi, Japan
TEL	022-717-7924
Email	miya@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Tsugita
Organization	Tohoku University School of Medicine
Division name	Department of Palliative Nursing, Health Science
Zip code
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Mayagi, Japan
TEL	022-717-7924
Homepage URL
Email	hiroyuki.tsugita@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University School of Medicine
Institute
Department

Funding Source
Organization	Management Expenses Grants
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
Address
Tel
Email

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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2018 Year 07 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
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	2018 Year 06 Month 26 Day
Date of IRB	2019 Year 06 Month 18 Day
Anticipated trial start date	2018 Year 08 Month 13 Day
Last follow-up date	2019 Year 03 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	2018 Year 07 Month 30 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038277