UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047788 |
|---|---|
| Receipt number | 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 19:58:37 |
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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
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
ubuntu_koromo@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054481
