UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory Clinical Study on Combination Therapy with Anamorelin and Component Nutrients for Cancer Cachexia Complicated by Pancreatic Cancer
Acronym	Evaluation of the Efficacy of Anamorelin and Component Nutrient Combination Therapy for Pancreatic Cancer Cachexia
Scientific Title	Exploratory Clinical Study on Combination Therapy with Anamorelin and Component Nutrients for Cancer Cachexia Complicated by Pancreatic Cancer
Scientific Title:Acronym	Evaluation of the Efficacy of Anamorelin and Component Nutrient Combination Therapy for Pancreatic Cancer Cachexia
Region	Japan

Condition
Condition	pancreatic carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical significance of anamorelin and component nutritional combination therapy in pancreatic cancer patients with cancer cachexia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle mass:On CT images, the total skeletal muscle mass at the level of the third lumbar vertebrae is measured using SYNAPSE VINCENT.
Key secondary outcomes	STAS,weight gain,grip strength

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Anamorelin 100 mg/day, upon waking Elental 600 kcal/day These will be administered for 12 weeks and evaluated. After 13 weeks, patients will be followed up with or without medication until the final outcome.
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	95 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with pancreatic cancer complicated with pre-cachexia or cachexia who are undergoing treatment at our hospital. Patients must be between 20 and 95 years of age at the time of enrollment. Written consent for participation in the study has been obtained from the subjects themselves.
Key exclusion criteria	Patients with a history of other cancers, and who have been treated for these cancers within 1 year. Patients with liver disease Cases in which the patient is pregnant, under 20 years of age, or unable to give consent Cases in which the patient has requested to withdraw consent by disclosing information. Other research subjects whom the principal investigator or physician in charge deems inappropriate for the safe implementation of this study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Ogura
Organization	Osaka Medical and Pharmaceutical University
Division name	2nd Department of Internal Medicine
Zip code	5690801
Address	2-7, Daigakumachi, Takatsuki City, Osaka
TEL	0726831221
Email	oguratakeshi0411@yahoo.co.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Okuda
Organization	Osaka Medical and Pharmaceutical University
Division name	2nd Department of Internal Medicine
Zip code	5690801
Address	2-7, Daigakumachi, Takatsuki City, Osaka
TEL	0726831221
Homepage URL
Email	ubuntu_koromo@yahoo.co.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	Osaka Medical and Pharmaceutical 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	Osaka Medical and Pharmaceutical University Research Ethics Committee
Address	2-7, Daigakumachi, Takatsuki City, Osaka
Tel	0726831221
Email	rinri@ompu.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	2022 Year 05 Month 20 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	Preinitiation
Date of protocol fixation	2021 Year 07 Month 21 Day
Date of IRB	2021 Year 08 Month 19 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2024 Year 09 Month 01 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 05 Month 18 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054481

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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