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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051354


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name