![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | pancreatic carcinoma | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |