UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032845 |
|---|---|
| Receipt number | R000037445 |
| Scientific Title | A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2021/12/04 16:56:54 |
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Basic information
Public title
A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Acronym
A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Scientific Title
A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Scientific Title:Acronym
A randomized multi-center phase II study on the efficacy of postoperative Rikkunshito plus Elental in gastric cancer patients with adjuvant chemotherapy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
preventional efficacy of body composition decline (body weight, muscle mass, fat mass)
nutrition index (Alb, TP, T-Chol, prealubmin, NLR)
compliance of adjuvant chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
change rate of mascle mass 6 months after intervention
Key secondary outcomes
change rate of body weight and fat mass 6 months after intervention
nutrition index
compliance of adjuvant chemotherapy
drug safty
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dayly administration of ELENTAL (300kcal) for 6 months from the start of adjuvant chemotherapy
Interventions/Control_2
Dayly administration of ELENTAL (300kcal) and Rikkunshito 7.5g for 6 months from the start of adjuvant chemotherapy
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 who received R0 resection by distal or proximal gastrectomy
2) Patients who will receive adjuvant chemotherapy
3) Patients with apptite loss or malnutrition on POD 7
4) Patients without severe complications (heart disease, pulmonary fibrosis, intestinal pneumonia, bleeding tendency)
5) Patients who will be alive for more than 6 months
6) Patients who can take oral nutrition
7) Patients whose age is more than 20
8) Patients who approved written informed consent
Key exclusion criteria
1) Patients with another malignant neoplasm
2) Patients who received preoperative chemo- or radiotherapy
3) Patients with preoperative malnutrition (alb less than 3.0g per dl)
4) Patients who were administrated Kanpo
5) Patients with allergy of ELENTAL
6) Patients with history of Kanpo allergy
7) Patients with severe psychiatric disorder
8) Patients who was considered ineligible by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sachio |
| Middle name | |
| Last name | Fushida |
Organization
Kanazawa University Hospital
Division name
Gastroenterological Surgery
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2362
fushida@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachio |
| Middle name | |
| Last name | Fushida |
Organization
Kanazawa University Hospital
Division name
Gastroenterological Surgery
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2362
Homepage URL
fushida@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
NPO corporation Digestive Disorder Support Organization (DDSO)
Institute
Department
Personal name
Funding Source
Organization
NPO corporation Digestive Disorder Support Organization (DDSO)
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
Innovative Clinical Research Center, Kanazawa University
Address
13-1 Takara-machi, Kanazawa
Tel
076-265-2000
hpsangak@adm.kanazawa-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
| 2018 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037445
