UMIN-CTR Clinical Trial

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
Email	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
Email	izumo_takehiro@med.jrc.or.jp

Sponsor
Institute	Department of Respiratory Medicine, Japanese Red Cross Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051354