UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045122 |
|---|---|
| Receipt number | R000051546 |
| Scientific Title | Prospective evaluation on the effects of anamorelin on blood zinc level and changes in grip strength in advanced gastrointestinal cancer patients with cancer cachexia |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2022/02/20 21:22:32 |
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Basic information
Public title
Prospective evaluation on the effects of anamorelin on blood zinc level and changes in grip strength in advanced gastrointestinal cancer patients with cancer cachexia
Acronym
anamo-zinc study
Scientific Title
Prospective evaluation on the effects of anamorelin on blood zinc level and changes in grip strength in advanced gastrointestinal cancer patients with cancer cachexia
Scientific Title:Acronym
anamo-zinc study
Region
| Japan |
Condition
Condition
gastric cancer/ colorectal cancer/ pancreatic cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether anamorelin treatment of patients with cancer cachexia from gastric, colorectal, and pancreatic cancers results in the previously reported increase in body weight and lean body mass, as well as an increase in blood zinc levels and grip strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in blood zinc levels after 3 weeks (Allow 1 week before or after) of anamorelin administration
Key secondary outcomes
Improvement in grip strength and body composition measurements, change from baseline in LBM and body weight at each assessment period, change from baseline in appetite-related item scores according to the patient pamphlet, dose intensity and occurrence of side effects in patients undergoing chemotherapy
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
a. Patients who are eligible for administration of anamorelin
b. Patients who have obtained the written consent of the patient or his/her substitute to participate in the study
Key exclusion criteria
a. Patients with contraindications to the administration of anamorelin
b. Patients who are judged by the attending physician, or the department or facility to which the attending physician belongs, to be undesirable to participate in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Akazawa |
Organization
Sendai City Medical Center Sendai Open hospital
Division name
Department of gastrointestinal surgery
Zip code
9830824
Address
Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-252-1111
naoyakazawa@openhp.or.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Akazawa |
Organization
Sendai City Medical Center Sendai Open hospital
Division name
Department of gastrointestinal surgery
Zip code
9830824
Address
Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
TEL
0229252-1111
Homepage URL
k.tochikubo@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center Sendai Open hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Sendai City Medical Center Sendai Open hospital
Address
Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
Tel
022-252-1111
naoyakazawa@openhp.or.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 | 08 | Month | 16 | 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 | 16 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study outcomes shall rapidly be published after analysis of the data.
Management information
Registered date
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2022 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051546
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
