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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045611
Receipt No. 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 2021/10/09

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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
Condition Pancreatic cancer
Gastric cancer
Colorectal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

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 Medicine
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 Internal Medicine (Metabolism, Immunology, Gastroenterology and Hematology)
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
Institute Asahikawa Medical University
Department of Medicine, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology
Institute
Department

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
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
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 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
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 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
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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
2021 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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