UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046056 |
|---|---|
| Receipt number | R000052565 |
| Scientific Title | Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2024/07/30 11:12:47 |
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Basic information
Public title
Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Acronym
Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Scientific Title
Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Scientific Title:Acronym
Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of anamorelin in chemotherapy using S-1 for unresectable advanced or postoperative recurrent gastric cancer patients with cachexia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight change rate 12 weeks 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are scheduled or undergoing chemotherapy containing S-1 for unresectable advanced gastric cancer or postoperative recurrent gastric cancer
2. Patients with cachexia who are covered by anamorelin insurance: Within 6 months, 5% or more weight loss and loss of appetite are observed, and two or more of the following A to C are observed.
(A) Fatigue or fatigue
(B) Weakness of the whole body
(C) One or more of CRP> 0.5mg / dL, Hb <12g / dL, Alb <3.2g / dL
3. Patients scheduled to receive anamorelin
4. Patients who have received sufficient explanation before participating in this study, and who have obtained the patient's free will to consent to the document after sufficient understanding.
Key exclusion criteria
1. Patients with gastrointestinal disorders who have difficulty in taking food orally or who require gastrointestinal rest
2. Patients with congestive heart failure, underlying heart disease (valvular disease, cardiomyopathy, etc.), history of myocardial infarction or angina, conduction system disorder, risk of QT interval prolongation or a history thereof
3. Patients with a history of administration of anthracyclines
4. Patients receiving strong CYP3A4 inhibitors (drugs containing clarislomycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir, cobicistat)
5. Patients who have confirmed ascites in an amount exceeding the physiological range
6. Patients with confirmed pleural effusion
7. Patients with moderate or higher liver dysfunction (Child-Pugh classifications B and C)
8. Patients judged by the attending physician to be inappropriate for participation in the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Hatao |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
0423235111
fchobi@gmail.com
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Hatao |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
0423235111
Homepage URL
fchobi@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Tama Medical Center
Department of Surgery
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
Tel
042-323-5111
tamarinshou@tmhp.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 | 11 | Month | 15 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
3
Results
ANA was effective in 1st line gastric cancer chemotherapy patients, but not in patients using it after the 2nd line.
In patients with postoperative recurrence, ANA could not be used while using S-1, probably due to insurance restrictions (weight loss rate criteria).
Results date posted
| 2024 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with advanced/recurrent gastric cancer undergoing S-1 and anamorelin insurance indication
Participant flow
Patients with advanced/recurrent gastric cancer undergoing S-1 and anamorelin insurance indication
Adverse events
None
Outcome measures
% weight change
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When chemotherapy containing S-1 is being or will be given and cachexia is confirmed, the study will be described once it has been confirmed that it meets other indication criteria and does not meet the exclusion criteria.
Anamorelin will be administered with reference to the package insert. When visiting a medical institution for outpatient chemotherapy, etc., the continuation of anamorelin confirms the patient's intention as much as possible for each prescription to see if the test can be continued by blood tests and interviews. Anamorelin will end 12 weeks after the start, according to the insurance coverage criteria. Body weight, blood findings, interviews, etc. will be conducted even 4 weeks after the end of anamorelin. If S-1 is ineffective or discontinued due to an adverse event, anamorelin dosing is medically acceptable and will continue for up to 12 weeks if the patient so desires. Medication will be discontinue if the patient does not wish to continue anamorelin or if there are serious adverse events caused by anamorelin. Even if anamorelin is discontinued, evaluation and observation for the study will continue with the consent of the patient.
Management information
Registered date
| 2021 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052565
