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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033563
Receipt No. R000038277
Scientific Title Acupressure for Nausea and Vomiting in end of life cancer patients:Pilot Study
Date of disclosure of the study information 2018/07/31
Last modified on 2019/07/30

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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

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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