UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032442
Receipt No. 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 2018/04/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name ken shirabe
Organization Gunma University Hospital
Division name Hepatobiliary and Pancreatic Surgery
Zip code
Address 3-39-22, Showa-machi, Maebashi, Gunma
TEL 027-220-8224
Email kshirabe@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiharu Kimura
Organization Gunma University Hospital
Division name Gastroenterological Surgery
Zip code
Address 3-39-22, Showa-machi, Maebashi, Gunma
TEL 027-220-8224
Homepage URL
Email akimura@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
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
2018 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.