UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032442 |
|---|---|
| Receipt number | R000036410 |
| Scientific Title | A randomized controlled trial to assess the efficacy and safety of RACOL for adverse events such as stomatitis and malnutrition during adjuvant chemotherapy of gastric cancer patients |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2025/05/07 23:56:52 |
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Basic information
Public title
A randomized controlled trial to assess the efficacy and safety of RACOL for adverse events such as stomatitis and malnutrition during adjuvant chemotherapy of gastric cancer patients
Acronym
A randomized controlled trial to assess the efficacy and safety of RACOL during adjuvant chemotherapy of gastric cancer patients
Scientific Title
A randomized controlled trial to assess the efficacy and safety of RACOL for adverse events such as stomatitis and malnutrition during adjuvant chemotherapy of gastric cancer patients
Scientific Title:Acronym
A randomized controlled trial to assess the efficacy and safety of RACOL during adjuvant chemotherapy of gastric cancer patients
Region
| Japan |
Condition
Condition
Gastric cancer performed adjuvant chemotherapy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of omega-3 fatty acid-containing enteral nutrition for stomatitis and malnutrition by adjuvant chemotherapy with S-1 in gastric cancer patients after operation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of stomatitis and malnutrition
Key secondary outcomes
1) The incidence of non-hematotoxicity (anorexia, diarrhea, vomiting)
2) The incidence of hematotoxicity
3) Completion rate of chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Racol(omega-3 fatty acid-containing enteral nutrition) once a day for 28days during 1 and 2 course of S-1 adjuvant therapy.
Interventions/Control_2
No medication
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who diagnosed as gastric cancer by cytology or histology.
2) Patients who will receive S-1 adjuvant chemotherapy.
3) Patients who diagnosed as Stage II-III gastric cancer.
4) Performance status (PS) 0-2.
5) Patients who don't receive chemotherapy or radiation.
6) Patients can administer omega-3 fatty acid -containing enteral nutrition.
7) Patients whose function of main organ (bone marrow, heart, liver, kidney, lung, etc) are maintained and satisfy the following conditions.
White blood cell count over 4,000/mm3, under 12,000/mm3.
Neutrophils over 2,000/mm3.
Blood platelet count over 100,000/mm3.
Hemoglobin over 9.5 g/dl.
ALT,AST under 1.5 times the upper limit of normal.
Total bilirubin under 1.2 mg/dl.
ALP under 2.5 times the upper limit of normal.
Creatinine under 1.2 mg/dl.
BUN under the upper limit of normal.
8) patients with at least 3 months of life-expectancy.
9)Gender: unmentioned.
10)Inpatient admission or outpatient: unmentioned.
11) Siged, written informed concent is obtained.
Key exclusion criteria
1) Patients with drug allergy of omega-3 faty acid-containing enteral nutrition.
2) patients with severe complications (heart disease, pulumonary fibrosis, interstitial pneumonia, bleeding tendency).
3) Patients with fever or severe infection.
4) Patients with active double cancer.
5) Patients with paralysis, peripheral neuropathy and edema.
6) Patients with active pleural or pericardial effusion.
7) Patients with severe drug allergy.
8) Patients who are pregnant, suspected to be pregnant or breastfeeding.
9) Patients with severe psychiatric disorder.
10) The patient who was considered ineligible by the investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | ken |
| Middle name | |
| Last name | shirabe |
Organization
Gunma University Hospital
Division name
Hepatobiliary and Pancreatic Surgery
Zip code
3718511
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8224
kshirabe@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiharu |
| Middle name | |
| Last name | Kimura |
Organization
Gunma University Hospital
Division name
Gastroenterological Surgery
Zip code
3718511
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8224
Homepage URL
akimura@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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 Institutional review board
Address
3-39-22, Showa-machi, Maebashi, Gunma
Tel
027-220-8740
gunmaciru-office@umin.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
| 2018 | Year | 06 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036410
