UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056761 |
|---|---|
| Receipt number | R000064873 |
| Scientific Title | A Prospective Interventional Study on the Effectiveness of Cancer Chemotherapy Combined with Immunenutrition for Esophageal Cancer |
| Date of disclosure of the study information | 2025/01/21 |
| Last modified on | 2025/01/20 18:25:12 |
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Basic information
Public title
A Study on the Effectiveness of Cancer Chemotherapy Combined with Immunenutrition for Esophageal Cancer
Acronym
A Study on the Effectiveness of Cancer Chemotherapy Combined with Immunenutrition for Esophageal Cancer
Scientific Title
A Prospective Interventional Study on the Effectiveness of Cancer Chemotherapy Combined with Immunenutrition for Esophageal Cancer
Scientific Title:Acronym
A Prospective Interventional Study on the Effectiveness of Cancer Chemotherapy Combined with Immunenutrition for Esophageal Cancer
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of immunenutrition in combination with cancer chemotherapy in improving treatment efficacy and treatment completion rates.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effect of immunonutritional therapy on the therapeutic efficacy and adverse events of cancer chemotherapy by measuring blood levels of Arachidonic acid (AA), Eicosa pentaenoic acid (EPA) and Docosa hexaenoic acid (DHA), which are believed to be the main factors that improve immunity with immunonutritional therapy, and in vivo factors such as IL-6, which is an indicator of immunity. Evaluate the impact of immunonutritional therapy on treatment efficacy and adverse events, as well as the factors and mechanisms underlying these effects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of side effects, progression-free survival, primary tumor shrinkage rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients diagnosed with esophageal cancer and decided to receive chemotherapy or chemoradiotherapy were randomly assigned to the Concomitant use of Prosure group. The basic dose will be set at 2 bottles of Prosure per day, and patients who are able to take the equivalent of 14 or more bottles during 14 days will be assigned to the Prosure group.
Interventions/Control_2
Patients diagnosed with esophageal cancer and decided to receive chemotherapy or chemoradiotherapy were randomly assigned to control group. The basic dose will be set at 2 bottles of Prosure per day, and patients who are able to take the equivalent of 14 or more bottles during 14 days will be assigned to the Prosure group.
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 undergoing chemotherapy or chemoradiotherapy for esophageal cancer at Gunma University Hospital
(2) Patients of any gender
(3) Patients must be at least 20 years of age.
(4) Patients who have been fully informed about the participation in this study, fully understand the study, and have given written consent of their own free will.
Key exclusion criteria
(1) Patients with diabetes mellitus for whom nutritional supplements are deemed inappropriate
(2) Patients who are unable to take oral intake
(3) Patients who are judged to be unsuitable for the product by the physician's judgment
(4) Patients who are taking EPA preparations
(5) Patients who plan to take general medicines or nutritional foods containing high concentrations of EPA or DHA during treatment.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kuwano |
Organization
Okagaki Hospital
Division name
Regional Comprehensive Support Center
Zip code
8114204
Address
145 Teno, Onga-gun, Okagaki-machi, Fukuoka-ken
TEL
0932820181
kuwano@onmah.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Yashima |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma-ken
TEL
0272208727
Homepage URL
gyashima@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma-ken
Tel
0272208740
irb-jimukk-ciru@ml.gunma-u.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
| 2025 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
22
Results
Because the number of cases did not reach the target number, it was not possible to assess the impact of Prosure administration on the primary outcome.
Results date posted
| 2025 | Year | 01 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-two patients were enrolled, 13 in the ProSure group and 9 in the control group. Of the 13 patients in the ProSure group, 8 were excluded because their average intake rate of ProSure was less than 1 bottle/day.
Participant flow
Patients diagnosed with esophageal cancer in the usual care setting and scheduled to receive cancer chemotherapy or chemoradiotherapy were asked to provide written information about the study and to give their consent. Patients who gave consent were randomly assigned to the ProSure or control group. Immediately before and after the start of treatment, blood samples were drawn by the treating physician for analysis of blood constituents. At the same time, the efficacy of the treatment will be followed up after the start of treatment.
Adverse events
There were no significant differences in side effects between the Prosure and control groups.
Outcome measures
Progression-free survival and primary tumor reduction rates were not significantly different between the Prosure and control groups.
Free fatty acids in the blood were significantly higher in the ProSure group than in the control group for EPA/AA, but no difference was observed for DHA/AA between the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064873
