UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045059 |
|---|---|
| Receipt number | R000051354 |
| Scientific Title | Prospective study on the efficacy and safety of anamorelin for cachexia and identification of predictors of efficacy |
| Date of disclosure of the study information | 2021/08/05 |
| Last modified on | 2021/08/04 10:48:14 |
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Basic information
Public title
Prospective study on the efficacy and safety of anamorelin for cachexia and identification of predictors of efficacy
Acronym
Anamorelin prospective study
Scientific Title
Prospective study on the efficacy and safety of anamorelin for cachexia and identification of predictors of efficacy
Scientific Title:Acronym
Anamorelin prospective study
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Chest surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Proactively examine the efficacy, safety and efficacy predictors of anamorelin for cachexia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients who maintained or increased lean body mass by the 4-Compartment model (4C) method 8 weeks after anamorelin administration
Key secondary outcomes
1. Change in lean body mass from baseline at each time of evaluation
2. Amount of change from baseline in total weight at each evaluation period
3. 3. Amount of change in grip strength from baseline at each evaluation period
4. Amount of change in skeletal muscle mass index (SMI) at each evaluation period
5. FAACT score Average change over 8 weeks from each baseline
6. Average change from baseline in total FAACT score for 8 weeks
7. 8-week average change from baseline in serum protein (TP) and albumin (Alb)
8. Changes in ECOG performance status (PS)
9. Factors that predict the primary and secondary endpoints
10. Incidence of Grade 1 or higher adverse events during treatment
If continuous treatment with the drug is continued after 11.8 weeks, the adverse events, lean body mass, FAACT score, anamorelin oral administration period, and survival period should be reduced as much as possible from the start of the drug treatment to 1 year later.
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
1) Cancer cachexia patients associated with non-small cell lung cancer
2) Stage III or stage III / IV or postoperative recurrence non-small cell lung cancer for which chemoradiotherapy is indicated
3) Allow 5% or more non-arbitrary weight loss within the last 6 months
4) Meet the following criteria for cancer cachexia
Anorexia
Satisfy 2 or more of the following 4 items
a) Fatigue or malaise, b) Generalized muscle weakness, c) Brachial muscle circumference (cm) <10th percentile (less than the bottom 10% of the distribution of brachial muscle circumference), d) Satisfy at least one of the following three items [1. C reactive protein (CRP) value greater than 0.5 mg / dL, 2. hemoglobin (Hb) value less than 12 g / dL, 3. albumin value less than 3.2 g / dL]
5) Patients who have written consent to participate in this study
6) Patients over 20 years old
Key exclusion criteria
1) Patients who have previously been treated with anamorelin
2) Patients who are contraindicated for administration according to the package insert
3) Other patients who are judged to be inappropriate as a target by the judgment of a doctor
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Department of Respiratory Medicine
Zip code
1508935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
izumo_takehiro@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Department of Respiratory Medicine
Zip code
1508935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
Homepage URL
izumo_takehiro@med.jrc.or.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Japanese Red Cross Medical Center
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
Japanese Red Cross Medical Center
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
Tel
03-3400-1311
drtake1118@gmail.com
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 | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study
Management information
Registered date
| 2021 | Year | 08 | Month | 04 | Day |
Last modified on
| 2021 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051354
