UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Acupuncture Therapy on Anorexia in Chronic Pulmonary diseases
Acronym	EAT-ACUP trial
Scientific Title	Efficacy and safety of acupuncture on anorexia and dietary intake loss in patients with chronic respiratory disease (randomized controlled trial)
Scientific Title:Acronym	Effects of acupuncture on anorexia in Chronic respiratory disease (RCT)
Region	Japan

Condition
Condition	Chronic respiratory disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the efficacy and safety of acupuncture to improve anorexia and dietary intake loss, and to maintain body weight among patients with chronic respiratory diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS score for appetite
Key secondary outcomes	1) Food intake 2) Body Mass Index 3) nutrition status (Alb, Pre-Alb, retinol-binding protein) 4) 24-hour heart rate variability

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Acupuncture group (group that adds acupuncture to standard treatment) Twice a week for 5 weeks
Interventions/Control_2	Control group (normal treatment group) 5 weeks
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with chronic respiratory disease who have very low food intake due to loss of appetite 2) Patients with weight loss (5% or more / 6 months) or low BMI (<20 kg / m2) 3) Patients who consented in writing 4) Patients who the doctor has determined to be stable.
Key exclusion criteria	1) Patients with malignant tumors 2) Patients with serious heart disease 3) Patients with severe liver dysfunction 4) Patients with severe renal dysfunction 5) Patients with severe asthma factors 6) Patients with collagen disease (RA, PM / DM, etc.) 7) Patients who have undergone drug changes during clinical trials 8) Patients who have already received acupuncture 9) Patient judged as inappropriate by the researchers
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Kida
Organization	National Hospital Organization Osaka Toneyama Medical Center
Division name	Department of Respiratory Medicine
Zip code	560-8552
Address	5-1-1 Toneyama, Toyonaka, Osaka
TEL	+81668532001
Email	kida.hiroshi.sv@mail.hosp.go.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	Respiratory Science Laboratory
Zip code	560-8552
Address	5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan
TEL	+81668532001
Homepage URL
Email	maekura.acupuncture@gmail.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	+81668532001
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	2022 Year 04 Month 26 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	2022 Year 04 Month 15 Day
Date of IRB	2022 Year 04 Month 18 Day
Anticipated trial start date	2022 Year 04 Month 26 Day
Last follow-up date	2024 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	2022 Year 04 Month 26 Day
Last modified on	2022 Year 04 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054272