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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028304
Receipt No. R000032401
Scientific Title The effect of Contact Needle Therapy for fatigue of cancer patients in palliative care wards
Date of disclosure of the study information 2017/07/21
Last modified on 2019/07/22

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Basic information
Public title The effect of Contact Needle Therapy for fatigue of cancer patients in palliative care wards
Acronym The effect of Contact Needle Therapy for fatigue of cancer patients in palliative care wards
Scientific Title The effect of Contact Needle Therapy for fatigue of cancer patients in palliative care wards
Scientific Title:Acronym The effect of Contact Needle Therapy for fatigue of cancer patients in palliative care wards
Region
Japan

Condition
Condition fatigue
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Fatigue associated with cance is defined as consistent subjective physical, emotional and or cognitive fatigue or exhaustion which related with cancer or cancer treatment. In order to examine the improvement of symptoms or QOL (quality of life) by using contact needle therapy (CNT) in addition to standardized treatment for fatigue, its clinical efficacy and safety by examining patients' subjective assessment and objective assessment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numerical Rating Scale(NRS) of fatigue
Key secondary outcomes Cancer Fatigue Scale
Numerical Rating Scale of pain
Support Team Assessment Schedule
Palliative Prognostic Index
Palliative Performance Scale
Measurement of salivary amylase activity

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Contact Needle Therapy
Interventions/Control_2 non-treatment
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 cancer patients in the end stages of life who complain of fatigue
Patients terminated treatment
Key exclusion criteria Patients who are deemed unsuitable by researchers or investigators
Patients with metal allergies
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Keiko
Middle name
Last name Ogawa
Organization Kanazawa University Hospital
Division name Department of Japanese-Traditional (Kampo) Medicine
Zip code 9208641
Address 13-1, Takara-machi, Kanazawa
TEL 176-265-2918
Email okeiko@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Ogawa
Organization Kanazawa University Hospital
Division name Department of Japanese-Traditional (Kampo) Medicine
Zip code 920-8641
Address 13-1, Takara-machi, Kanazawa
TEL 076-265-2918
Homepage URL
Email okeiko@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University
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 Kanazawa University Hospital
Address 13-1, Takara-machi
Tel +819060322222
Email okeiko@med.kanazawa-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
2017 Year 07 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
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
2017 Year 07 Month 21 Day
Date of IRB
2017 Year 06 Month 29 Day
Anticipated trial start date
2018 Year 07 Month 21 Day
Last follow-up date
2022 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
2017 Year 07 Month 20 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032401

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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