UMIN-CTR Clinical Trial

Basic information
Public title	Effects of acupuncture for anorexia and dietary intake loss in patients with advanced respiratory illness (Pilot study)
Acronym	Effects of acupuncture on anorexia in advanced respiratory disease
Scientific Title	Effects of acupuncture for anorexia and dietary intake loss in patients with advanced respiratory illness (Pilot study)
Scientific Title:Acronym	Effects of acupuncture on anorexia in advanced respiratory disease
Region	Japan

Condition
Condition	advanced respiratory illness
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether acupuncture improves dietary intake through increased appetite stimulation, and maintains weight, and to evaluate the safety of acupuncture in patients with advanced respiratory illness.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	amount of food intake before and after acupuncture (three times a week for 3 weeks)
Key secondary outcomes	1) VAS score for appetite 2) nutrition status (Alb, Pre-Alb, retinol-binding protein) 3) appetite hormone (ghrelin) 4) catecholamines (norepinephrine, epinephrine, and dopamine) 5) 24-hour urinary catecholamine levels.

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	acupuncture three times a week for 3 weeks.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) severe chronic respiratory diseases 2) extremely reduced dietary intake due to poor appetite, despite receiving nutritional therapy 3) body weight loss of more than 5% in the last 6 months or BMI < 21 kg/m2 4) Patients who have signed the agreement for participation in this study
Key exclusion criteria	1) Patients with malignant tumours 2) Patients with serious cardiac disease 3) Patients with hepatic insufficiency 4) Patients with renal insufficiency 5) Patients whose drugs have been changed during the clinical trial 6) In addition to the above exclusion criteria, patients judged by their physician to be ineligible to participate in this study
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Ryoji Middle name Last name Maekura
Organization	Graduate School of Medical Safety Management, Jikei University of Health Care Sciences
Division name	Jikei University of Health Care Sciences
Zip code	532-0003
Address	1-2-8 Miyahara, Yodogawa-ku, Osaka, Japan
TEL	06-6150-1336
Email	r-maekura@ghsj.ac.jp

Public contact
Name of contact person	1st name Tomonori Middle name Last name Maekura
Organization	National Hospital Organization Osaka Toneyama Medical Center
Division name	Division of clinical reserach, laboratory of respiratory sciencekennkyuuinn
Zip code	560-8552
Address	5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL	06-6853-2001
Homepage URL
Email	m_tomonori@me.com

Sponsor
Institute	National Hospital Organization Osaka Toneyama Medical Center
Institute
Department

Funding Source
Organization	Grant-in-Aid for Clinical Research from National Hospital Organization in Japan
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	National Hospital Organization Osaka Toneyama Medical Center
Address	5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
Tel	06-6853-2001
Email	410-chiken@mail.hosp.go.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	2021 Year 07 Month 14 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	10
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	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 09 Month 16 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 14 Day
Last modified on	2021 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051215