UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047574 |
|---|---|
| Receipt number | R000054179 |
| Scientific Title | An observational study to explore the effects of anamorelin on gut microbiota in patients with carcinoma in situ with cachexia |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2025/04/25 11:23:06 |
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Basic information
Public title
Effects of anamorelin on microbiota
Acronym
does Anamorelin for patients with CAncer cachexia DEtermine their MICrobiota?
Scientific Title
An observational study to explore the effects of anamorelin on gut microbiota in patients with carcinoma in situ with cachexia
Scientific Title:Acronym
ACADEMIC study
Region
| Japan |
Condition
Condition
Cancer cachexia
Classification by specialty
| Medicine in general | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in gut microbiota and nutrition-related indices in carcinoma-bearing patients with cachexia who are eligible for oral anamorelin.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the diversity of intestinal microbiota before and after anamorelin administration
Key secondary outcomes
Change in body weight
Percent change in EORTC-QLQ-C15PAL score
Percent change in appetite-related items in EORTC-QLQ-C15PAL score
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-small cell lung cancer, pancreatic cancer, gastric cancer, or colorectal cancer
With at least 5% weight loss and loss of appetite within 6 months,
1) Fatigue or malaise
2) Generalized muscle weakness
3) Two or more of CRP>0.5mg/dL, Hb<12g/dL, ALB<3.2g/dL
ECOG-PS 0-2
Patients with consent of the study
Key exclusion criteria
Patients with a prognosis of 12 weeks or less
Previous anamorelin administration
Patients with concomitant severe cardiac disease
Hepatic dysfunction (Child-Pugh B or C)
Difficulty with oral intake due to organic abnormalities (e.g. obstruction) of the gastrointestinal tract
Other patients who are deemed inappropriate by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shogen |
| Middle name | |
| Last name | Boku |
Organization
Kansai Medical University Hospital
Division name
Cancer Treament Center
Zip code
5731191
Address
2-3-1 shin-machi, Hirakata-city, Osaka, Japan
TEL
0728040101
shogen0820@gmail.com
Public contact
Name of contact person
| 1st name | Shogen |
| Middle name | |
| Last name | Boku |
Organization
Kansai Medical University Hospital
Division name
Cancer Treament Center
Zip code
5731191
Address
2-3-1 shin-machi, Hirakata-city, Osaka, Japan
TEL
0728040101
Homepage URL
shogen0820@gmail.com
Sponsor or person
Institute
Cancer Treament Center, Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding, Kansai Medical 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
Ethics Review Center, Kansai Medical University
Address
Room 701, 7th Floor, School Building, 2-5-1 Shinmachi, Hirakata City, Osaka, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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 | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary endpoint of this study was changes in gut microbiota, but secondary endpoints included nutritional surveys and quality of life assessments. We would like to reconsider the importance of diet and nutrition in cancer treatment through multidisciplinary collaboration with nurses and dietitians.
Management information
Registered date
| 2022 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054179
