UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037236 |
|---|---|
| Receipt number | R000042450 |
| Scientific Title | Web questionnaire survey on cancer cachexia |
| Date of disclosure of the study information | 2019/07/07 |
| Last modified on | 2024/03/26 09:13:20 |
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Basic information
Public title
Web questionnaire survey on cancer cachexia
Acronym
J-EPOCC(Japanese Evidence for Patients Of Cancer Cachexia)
Scientific Title
Web questionnaire survey on cancer cachexia
Scientific Title:Acronym
J-EPOCC(Japanese Evidence for Patients Of Cancer Cachexia)
Region
| Japan |
Condition
Condition
cancer cachexia
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to (number one) clarify the level of understanding on cancer cachexia, and (number 2) to clarify the awareness of the problem for anorexia associated with Cancer
Basic objectives2
Others
Basic objectives -Others
opinion survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Daily assessment and measurement of anorexia and weight loss associated with cancer
2) Treatment status for anorexia and weight loss
3) Understanding and treatment status of cancer cachexia diagnostic criteria
Key secondary outcomes
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
Doctor who treats cancer patient of drug treatment stage of any of lung, gastric, esophageal, colorectal, liver, biliary, pancreatic cancer in more than 5 cases in the last 3 months
Medical staff such as nurses, pharmacists, nutritionist and physical therapists who are involved in cancer treatment (except nurses who work in clinics and clinics)
Patients with lung, gastric, esophageal, colorectal, liver, biliary, or pancreatic cancer who have been admitted to a medical institution for cancer treatment within one year and have a history of hospitalization.
For patients who have lung, gastric, esophageal, colorectal, liver, biliary or pancreatic cancer and who have been hospitalized or visited a medical institution for cancer treatment within one year, Family of over 20 years old
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical CO, LTD
Division name
Medical Affairs, Medical Planning 1
Zip code
103-0023
Address
9-11, Nihonbashi-Honcho 4-chome, Chuo-ku, Tokyo
TEL
03-5640-3701
tak.morimoto@ono.co.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Shiya |
Organization
Reno Medical K.K
Division name
Account Executive
Zip code
107-0052
Address
Nomura Tameike Building,1-1-14, Akasaka 1, Minato-ku, Tokyo
TEL
03-6229-8960
Homepage URL
research_support@reno.co.jp
Sponsor or person
Institute
Ono Pharmaceutical CO, LTD
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical CO, LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ono Pharmaceutical CO, LTD
Address
8-2, Kyutaromachi 1- Chome, Chuo-ku, Osaka-shi, Osaka, Japan
Tel
0662632992
tak.morimoto@ono.co.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
| 2019 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
https://jpn01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F32541173
Publication of results
Published
Result
URL related to results and publications
https://jpn01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F32668855
Number of participants that the trial has enrolled
2055
Results
Of all 538 patients, ca 30% worried about anorexia and ca 40% worried about weight loss after being diagnosed with cancer. In addition, many cancer patients thought that the cause of their symptoms was "side effects of anti-cancer drugs" or "due to the surgery." 245 patients (45.5%) experienced anorexia during cancer treatment, and 361 patients (67.1%) experienced weight loss.
Results date posted
| 2022 | Year | 10 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1) Physician survey: Physicians who have treated 5 or more patients with lung, stomach, esophageal, colon, liver, biliary tract, or pancreatic cancer in the last 3 months. 2) Survey of medical staffs: Nurses, pharmacists, nutrionists, and physical therapists involved in cancer treatment. 3) Patient survey: Patients aged 20 or older who have lung, stomach, esophageal, colon, liver, biliary tract, or pancreatic cancer, and who have been hospitalized or visited a medical institution for cancer treatment within the past year patients. 4) Family survey: Family members aged 20 years or older who live with a patient with lung, stomach, esophagus, colon, liver, biliary tract, or pancreatic cancer.
Participant flow
In July 2019, we conducted a Web questionnaire survey targeting physicians and medical staffs registered with "m3.com." and cancer patients and their families registered with "Research Panel Inc.". The goal of collecting responses was 500 each for physicians, medical staffs, patients, and their family members. In principle, the contents of the questionnaire were the same for physicians/medical staff, patients/families, but if the contents were specific to each subject, a different question was used.
Adverse events
There were no adverse events to be reported.
Outcome measures
Problem awareness of appetite loss and weight loss. The understanding of cancer cachexia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042450
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/12/03 | 家族用_J-EPOCC_アンケート調査票_190613修正.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
