UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051484 |
|---|---|
| Receipt number | R000058689 |
| Scientific Title | Nutritional management for patients with pancreatic cancer who receive proton therapy |
| Date of disclosure of the study information | 2023/06/29 |
| Last modified on | 2023/06/29 17:58:29 |
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Basic information
Public title
Nutritional management for patients with pancreatic cancer who receive proton therapy
Acronym
Nutritional management for patients with pancreatic cancer who receive proton therapy
Scientific Title
Nutritional management for patients with pancreatic cancer who receive proton therapy
Scientific Title:Acronym
Nutritional management for patients with pancreatic cancer who receive proton therapy
Region
| Japan |
Condition
Condition
Unresectable locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Radiology |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effects of pharmaceutical nutritional supplements and team intervention nutritional management in patients undergoing proton therapy for pancreatic cancer. First, can it maintain nutritional status; second, maintain or improve quality of life and help patients stay on course after treatment; and third, contribute to overall survival.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weigh the patients at the beginning of proton therapy, at the 10th irradiation, on the last day of treatment, and one month after completion of treatment, and measure the percentage of weight loss.
Key secondary outcomes
1. Compare quality of life assessments before treatment and one month after treatment completion with the EORTC QOL-C30.
2. Overall surivival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Three hours before the middle of the 6-hour fasting period, the patient should take a pharmaceutical nutritional supplement that is adopted by the hospital.
The radiologist adjusts the timing of irradiation to best suit the patient.
Nutritional guidance by a dietitian is provided at the first session, the 10th session of treatment, and the last day of treatment.
The nurse review the patient's pre-treatment dietary habits and select the best time to incorporate the treatment into the patient's lifestyle.
The nurse use the treatment diary to check dietary intake and treatment adverse events daily from the first day of irradiation to the last day of irradiation.
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
Patients undergoing radical proton therapy for pancreatic cancer at our Proton Therapy Center.
Patients diagnosed with unresectable locally advanced pancreatic cancer.
Patients must be at least 20 years of age to obtain consent.
Patients must be covered by insurance.
Patients must have a performance status of 0 to 2.
Key exclusion criteria
Patients with distant metastases or peritoneal dissemination.
Pediatric patients.
Patients who have been determined to have difficulty using the pharmaceutical nutritional products used in this study.
Patients who consume other than the pharmaceutical nutritional products used in this study during the fasting period.
Patients who are deemed by the treating physician to be unsuitable for inclusion in the study.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Kurano |
Organization
JISENKAI Healthcare Incorporated Foundation, Aizawa Hospital
Division name
Aizawa Comprehensive Cancer Center
Zip code
3908510
Address
2-5-1 Honjou Matsumoto-City, Nagano 390-8510 JAPAN
TEL
0263-33-8600
ai.73763@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Kurano |
Organization
JISENKAI Healthcare Incorporated Foundation, Aizawa Hospital
Division name
Aizawa Comprehensive Cancer Center
Zip code
Aizawa Comprehensive Cancer Center
Address
2-5-1 Honjou Matsumoto-City, Nagano 390-8510 JAPAN
TEL
0263338600
Homepage URL
https://aizawahospital.jp/clinical_research1/
kenkyu@ai-hosp.or.jp
Sponsor or person
Institute
Orhers
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Jisenkai
Address
2-5-1 Honjou Matsumoto-City, Nagano 390-8510 JAPAN
Tel
0263-33-8600
kenkyu@ai-hosp.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
社会医療法人財団 慈泉会 相澤病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 29 | 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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058689
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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