UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000045611
Receipt number	R000051285
Scientific Title	Impact of Anamorelin with unresectable pancreatic, gastric and colorectal cancer patients for a quality of life, skeletal muscle index and malnutrition
Date of disclosure of the study information	2021/10/01
Last modified on	2025/01/27 09:39:21

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Basic information

Public title

Impact of Anamorelin with unresectable pancreatic, gastric and colorectal cancer patients for a quality of life, skeletal muscle index and malnutrition

Acronym

Impact of Anamorelin for unresectable patients with pancreatic, gastric and colorectal cancer

Scientific Title

Impact of Anamorelin with unresectable pancreatic, gastric and colorectal cancer patients for a quality of life, skeletal muscle index and malnutrition

Scientific Title:Acronym

Impact of Anamorelin for unresectable patients with pancreatic, gastric and colorectal cancer

Region

Japan

Condition

Pancreatic cancer
Gastric cancer
Colorectal cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Assess the impact of Anamorelin for a quality of life (QOL) in patients with unresectable pancreatic, gastric and colorectal cancer patients

Basic objectives2

Others

Basic objectives -Others

Assess the impact of Anamorelin for skeletal muscle index, fat pad quantity and nutritional index in patients with unresectable pancreatic, gastric and colorectal cancer patients

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Assessment

Primary outcomes

Difference in QOL between non-Anamorelin usage and Anamorelin usage patients in 24 weeks (assessed by EORTC QLQ-C30)

Key secondary outcomes

1) Overall difference in QOL between non-Anamorelin usage and Anamorelin usage patients in 4, 12, 36 and 48 weeks (assessed by EORTC QLQ-C30)
2) Differences in QOL between non-Anamorelin usage and Anamorelin usage patients in 4, 12, 36 and 48 weeks by cancer types (assessed by EORTC QLQ-C30)
3) Progression free survival between non-Anamorelin usage and Anamorelin usage patients (analyzed by cancer types)
4) Overall survival between non-Anamorelin usage and Anamorelin usage patients (analyzed by cancer types)
5) Differences in skeletal muscle index between non-Anamorelin usage and Anamorelin usage patients in 12, 36 and 48 weeks (assessed by CT L3 level cross sectional imaging)
6) Differences in fat pad quantity between non-Anamorelin usage and Anamorelin usage patients in 12, 36 and 48 weeks (assessed by CT L3 level/umbilicus cross sectional imaging)
7) Differences in Neutrophil-to-Lymphocyte ratio, Platelet-to-Lymphocyte ratio, Prognostic Nutritional Index and modified Glasgow Prognostic Score between non-Anamorelin usage and Anamorelin usage patients in 4,8,12,24,36 and 48 weeks
8) Differences in serum Myostatin and ActivinA between non-Anamorelin usage and Anamorelin usage patients in 4,8,12,24,36 and 48 weeks
9) Differences in serum Myostatin and ActivinA between skeletal muscle index increased patients and skeletal muscle decreased patients in 12 and 24 weeks
10) Differences in skeletal muscle index between QOL increased and QOL decreased patients in 24 and 48 weeks.
11) Differences in body weight between Anamorelin usage and non-Anamorelin usage patient in 4, 8, 12, 24, 36 and 48 weeks

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. Patients who receives Anamorelin treatment
1) aged 20 years old or above
2) diagnosed as pancreatic cancer, gastric cancer or colorectal cancer by clinical imaging or other modalities
3) histologically proven cancer patients (including class IV by cytology or group IV by histology)
4) patients with unresectable state
5) written consent obtained from the patients or their legal representative
6) cancer cachexia patients who haven't improved general condition by nutritional support
7) Patients who have been losing weight more than 5% in the last 6 months and had more than 2 following symptoms;
7-1)Fatigue or malaise
7-2)Loss of muscular strength
7-3)Having 1 or more following data; CRP over 0.5mg/dl, Hb less than 12g/dl or Alb less than 3.2g/dl

2. Patients who does not receive Anamorelin treatment
1) aged 20 years old or above
2) diagnosed as pancreatic cancer, gastric cancer or colorectal cancer by clinical imaging or other modalities
3) histologically proven cancer patients (including class IV by cytology or group IV by histology)
4) patients with unresectable state
5) written consent obtained from the patients or their legal representative

Key exclusion criteria

1. Patients who receives Anamorelin treatment
1) under 20 years old
2) Patients with severe cardiac disease
3) Patients with severe liver disease (Child-Pugh B or C)
4) Patients with severe psychologic disease
5) Patients who is taking medications as follows; Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Telaprevir, Voriconazole, Ritonavir-containing agent or Cobicistat-containing agent
6) Unable to oral intake due to gastrointestinal occlusion or other organic gastrointestinal disorders
7) Unable to take part in this study due to other severe complication
8) Disqualified to take part in this study judged by attending/primary doctors
9) Patients with congestive heart failure, myocardial infarction, angina pectoris or severe cardiac conduction abnormalities

2. Patients who does not receive Anamorelin treatment
1) under 20 years old
2) Patients with severe cardiac disease
3) Patients with severe liver disease (Child-Pugh B or C)
4) Patients with severe psychologic disease
5) Unable to oral intake due to gastrointestinal occlusion or other organic gastrointestinal disorders
6) Unable to take part in this study due to other severe complication
7) Disqualified to take part in this study judged by attending/primary doctors

When the patient is determined not to qualify taking part in this study after the registration, the patients will be excluded from the study immediately.

Target sample size

249

Research contact person

Name of lead principal investigator

1st name Mikihiro

Middle name

Last name Fujiya

Organization

Asahikawa Medical University

Division name

Department of Internal Medicine, Division of Gastroenterology

Zip code

078-8510

Address

Asahikawa Medical University, 1-1, Midorigaoka Higashi 2-1, Asahikawa, Hokkaido, Japan

TEL

0166-68-2462

Email

fjym@asahikawa-med.ac.jp

Public contact

Name of contact person

1st name Hiroki

Middle name

Last name Sato

Organization

Asahikawa Medical University

Division name

Department of Internal Medicine, Division of Gastroenterology

Zip code

Asahikawa Medical University

Address

Asahikawa Medical University, 1-1, Midorigaoka Higashi 2-1, Asahikawa, Hokkaido, Japan

TEL

0166-68-2462

Homepage URL

Email

hirokisato@asahikawa-med.ac.jp

Sponsor or person

Institute

Asahikawa Medical University
Department of Medicine, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology

Institute

Department

Personal name

Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
Asahikawa City Hospital
Japanese Red Cross Asahikawa Hospital

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Asahikawa Medical University Research Ethics Office

Address

Asahikawa Medical University, 1-1, Midorigaoka Higashi 2-1, Asahikawa, Hokkaido, Japan

Tel

0166-68-2297

Email

rs-kk.g@asahikawa-med.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2021 Year 10 Month 01 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

194

Results

The primary outcome was the difference in QOL (quality of life) between the anamorelin hydrochloride treatment group and the non-treatment group at 24 weeks after the enrollment of the study, measured using EORTC QLQ-C30. On the functional scale, the treatment group showed significantly higher scores in physical functioning. On the symptom scale, the treatment group demonstrated significantly lower scores in dyspnea, loss of appetite, and financial difficulties.

Results date posted

2025 Year 01 Month 27 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

During the study period, 194 patients were enrolled, consisting of 94 males and 100 females, with a mean age of 68years and an average weight of 56.37kg. The primary diseases of the enrolled patients were as follows: 35 cases of gastric cancer, 65 cases of colorectal cancer, and 94 cases of pancreatic cancer (non-treatment group: gastric/colorectal/pancreatic cancer = 23/60/67 cases, treatment group: gastric/colorectal/pancreatic cancer=12/5/27 cases). The mean BMI of the patients was 20.94.

Participant flow

At the time of enrollment, CT imaging, blood test results, and remaining serum samples, as well as QOL evaluations, will be collected.
CT images taken within the scope of routine clinical care will be collected at 12, 24, 36, and 48 weeks.
Blood test results will be gathered at 4, 8, 12, 24, 36, and 48 weeks. Remaining serum samples will be collected at 4, 12, 24, and 48 weeks.
QOL evaluations will be conducted using the EORTC QLQ-C30 at 4, 12, 24 (primary endpoint), 36, and 48 weeks.

Adverse events

The non-serious adverse events were as follows:
Hyperglycemia (Grade 2): 1 case
Rash (Grade 2): 1 case
Both cases led to the discontinuation of the drug.

No serious adverse events were observed.

Outcome measures

1. Primary Endpoint
The difference in QOL (measured by EORTC QLQ-C30) between the anamorelin hydrochloride treatment group (exposed) and the non-treatment group (unexposed) at 24 weeks after the start of the study.

2. Secondary Endpoints
1.The difference in QOL (measured by EORTC QLQ-C30) at 4, 12, 36, and 48 weeks between the anamorelin hydrochloride treatment group and the non-treatment group for the entire study population.
2.The difference in QOL (measured by EORTC QLQ-C30) at 4, 12, 24, 36, and 48 weeks between the anamorelin hydrochloride treatment group and the non-treatment group for each cancer type.
3.The difference in skeletal muscle mass at the third lumbar vertebra (L3) on CT images at 12, 24, 36, and 48 weeks between the anamorelin hydrochloride treatment group and the non-treatment group.
4.The difference in fat mass at the third lumbar vertebra (L3) and umbilical cross-sections on CT images at 12, 24, 36, and 48 weeks between the anamorelin hydrochloride treatment group and the non-treatment group.
5.The difference in NLR, PLR, PNI, and mGPS at 4, 8, 12, 24, 36, and 48 weeks between the anamorelin hydrochloride treatment group and the non-treatment group.
6.The difference in serum myostatin and Activin A levels at 4, 12, 24, and 48 weeks between the anamorelin hydrochloride treatment group and the non-treatment group.
7.The difference in baseline myostatin and Activin A levels between subgroups of the anamorelin hydrochloride treatment group with maintained/increased muscle mass versus decreased muscle mass at the third lumbar vertebra (L3) cross-section at 12 and 24 weeks post-treatment.
8.The difference in body weight at 4, 8, 12, 24, 36, and 48 weeks between the anamorelin hydrochloride treatment group and the non-treatment group.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 09 Month 01 Day

Date of IRB

2021 Year 09 Month 13 Day

Anticipated trial start date

2021 Year 10 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 10 Month 02 Day

Date trial data considered complete

2024 Year 10 Month 31 Day

Date analysis concluded

Other

Other related information

Analyzing the efficacy of Anamorelin by quality of life, skeletal muscle, fat quantity and nutritional factors.

Management information

Registered date

2021 Year 09 Month 30 Day

Last modified on

2025 Year 01 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051285