UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061607 |
|---|---|
| Receipt number | R000070487 |
| Scientific Title | Adherence to Anamorelin and Changes in Quality of Life in Pancreatic Cancer Patients with Cachexia: A Multicenter, Observational Study |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/18 05:40:57 |
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Basic information
Public title
Observational Study on Adherence to Anamorelin and Changes in Quality of Life in Pancreatic Cancer Patients with Cachexia
Acronym
AQUA-PanC
Scientific Title
Adherence to Anamorelin and Changes in Quality of Life in Pancreatic Cancer Patients with Cachexia: A Multicenter, Observational Study
Scientific Title:Acronym
AQUA-PanC
Region
| Japan |
Condition
Condition
Pancreatic Cancer with Cachexia
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate longitudinal changes in medication adherence and health-related quality of life over 24 weeks in pancreatic cancer patients with cachexia receiving anamorelin. Medication adherence will be assessed using CubixxDT (Japanese version) and the Beliefs about Medicines Questionnaire (BMQ), while health-related quality of life will be evaluated using FAACT ACS and EQ-5D-5L.
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study of supportive care, quality of life, and medication adherence
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal changes in medication adherence rate to anamorelin assessed by CubixxDT (Japanese version) from baseline to 24 weeks.
Key secondary outcomes
Beliefs about medicines and medication adherence trends assessed by BMQ; Longitudinal changes in health related QOL scores assessed by FAACT ACS and EQ 5D 5L from baseline to 24 weeks; Association between medication adherence rates and health related QOL scores; Association between adherence rates measured by CubixxDT and BMQ scores; Exploratory analysis of reasons for non adherence
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Diagnosed with pancreatic cancer
2.Initiating anamorelin treatment for cancer cachexia
3.Age 18 years or older at registration
4.Written informed consent obtained
Key exclusion criteria
1.Unable to independently remove anamorelin tablets dispensed with CubixxDT Japanese version
2.Difficulty participating due to clinically significant psychiatric or neurological symptoms
3.Severe cognitive impairment
4.Native language is not Japanese
5.Unable to use ePRO
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Yamaguchi |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Pharmacy
Zip code
135-8550
Address
3-8-31 Ariake Koto-ku Tokyo Japan
TEL
03-3520-0111
masakazu.yamaguchi@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Kobayashi |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Pharmacy
Zip code
135-8550
Address
3-8-31 Ariake Koto-ku Tokyo Japan
TEL
03-3520-0111
Homepage URL
kazuo.sugita@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Tokyo Hospital
Showa Medical University Northern Yokohama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Japanese Foundation for Cancer Research
Address
3-8-31 Ariake Koto-ku Tokyo Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.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
| 2026 | Year | 05 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective multicenter observational study in pancreatic cancer patients with cancer cachexia. Patients receiving anamorelin in routine clinical practice will undergo medication adherence assessment using CubixxDT Japanese version and QOL assessment using ePRO over 24 weeks. No additional intervention or invasive procedure will be performed. Longitudinal changes will be evaluated using medical records, electronic medication adherence records, FAACT ACS, EQ 5D 5L, and BMQ.
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070487
