UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028304
Receipt number 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 2024/03/15 09:21:03

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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 Takumi
Middle name
Last name Taniguchi

Organization

Kanazawa University Hospital

Division name

Department of Anesthesiology

Zip code

9208641

Address

13-1, Takara-machi, Kanazawa

TEL

176-265-2918

Email

ikkandoo@gmail.com


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 or person

Institute

Kanazawa University

Institute

Department

Personal name



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

No longer 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

2024 Year 03 Month 15 Day



Link to view the page

Value
https://center6.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
2024/03/15 COPAM study:UMIN固定用シート別(識別番号・個人名削除済み).xlsx