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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047788
Receipt No. R000054481
Scientific Title Exploratory Clinical Study on Combination Therapy with Anamorelin and Component Nutrients for Cancer Cachexia Complicated by Pancreatic Cancer
Date of disclosure of the study information 2022/05/20
Last modified on 2022/05/19

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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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