UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044653 |
|---|---|
| Receipt number | R000050998 |
| Scientific Title | Analysis of endocrinological examination and lymphocyte composition of the peripheral blood in patients taking anamorelin |
| Date of disclosure of the study information | 2021/06/25 |
| Last modified on | 2023/06/26 09:18:13 |
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Basic information
Public title
Analysis of endocrinological examination and lymphocyte composition of the peripheral blood in patients taking anamorelin
Acronym
Analysis of endocrinological examination and lymphocyte composition of the peripheral blood in patients taking anamorelin
Scientific Title
Analysis of endocrinological examination and lymphocyte composition of the peripheral blood in patients taking anamorelin
Scientific Title:Acronym
Analysis of endocrinological examination and lymphocyte composition of the peripheral blood in patients taking anamorelin
Region
| Japan |
Condition
Condition
Patients with cancer cachexia
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparatively analyze the hormone levels and immune function before and after anamorelin administration in patients with cancer cachexia
Basic objectives2
Others
Basic objectives -Others
Analyze the effect of anamorelin: measure the weight before, 3 weeks, and 12 weeks after anamorelin administration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparatively analyze the hormone levels and immune function before and after anamorelin administration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with gastric cancer, pancreatic cancer, or colorectal cancer who are planned to start taking anamorelin
Key exclusion criteria
Women who are pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862357218
iwamuromasaya@yahoo.co.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
| 2021 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://ousar.lib.okayama-u.ac.jp/en/journal/amo/77/3/article/65488
Number of participants that the trial has enrolled
13
Results
At week 3, anamorelin administration resulted in body weight gain and increased the levels of growth hormone and HbA1c, as well as insulin-like growth factor-1 standard deviation scores (IGF-1 SD scores). At the same time, negative correlations were observed between deltaIGF-1 SD score and deltathyroidstimulating hormone (TSH) and between deltaIGF-1 SD score and deltafree testosterone. deltaBody weight and deltaIGF-1 SD score correlated positively at week 12.
Results date posted
| 2023 | Year | 06 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 26 | Day |
Baseline Characteristics
This study aimed to determine how anamorelin affects the endocrine system in patients with gastrointestinal cancer and cachexia. We prospectively enrolled 13 patients and comprehensively investigated their body weight and levels of serum albumin, hemoglobin A1c (HbA1c), and hormones before (week 0) and 3 and 12 weeks after anamorelin administration. The variables were evaluated at week 3 in 9 patients and at week 12 in 5 patients.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050998
