UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026758 |
|---|---|
| Receipt number | R000030580 |
| Scientific Title | Efforts to maintain the quality of Life for patients with malignant lymphoma undergoing chemotherapy |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/03/29 14:33:08 |
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Basic information
Public title
Efforts to maintain the quality of Life for patients with malignant lymphoma undergoing chemotherapy
Acronym
Maintenance of QOL for patients with malignant lymphoma
Scientific Title
Efforts to maintain the quality of Life for patients with malignant lymphoma undergoing chemotherapy
Scientific Title:Acronym
Maintenance of QOL for patients with malignant lymphoma
Region
| Japan |
Condition
Condition
Malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find out new approaches to maintain quality of life in the patients with malignant lymphoma treated with chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of muscle mass by body composition analyzer, InBody
Key secondary outcomes
Patient characteristics including age,sex,pathology,staging,chemotherapy effets.
Side effects related with chemotherapy.
Questionnaire survey with SF-36.
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 with B-cell malignant lymphoma were treated by R-CHOP therapy with or without BCAA.
[group 1]therapy with 2 pack of the BCAA-enriched supplement (aminofeel, TERUMO)
Interventions/Control_2
[group 2]therapy without BCAA-enriched supplement
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)B-cell malignant lymphoma
2)No dementia
3)Patients with informed consent by self judgment
Key exclusion criteria
1)multiple organ failure
2)progressive diseases during R-CHOP therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Shimizu |
Organization
Toho University Medical Center Sakura Hospital
Division name
Center for Diabetes, Metabolism and Endocrinology
Zip code
Address
564-1 Shimoshizu, Sakura City, Chiba 285-8741
TEL
043-462-8811
naomis-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Shimizu |
Organization
Toho University Medical Center Sakura Hospital
Division name
Center for Diabetes, Metabolism and Endocrinology
Zip code
Address
564-1 Shimoshizu, Sakura City, Chiba 285-8741
TEL
043-462-8811
Homepage URL
naomis-cib@umin.ac.jp
Sponsor or person
Institute
Toho University Medical Center Sakura Hospital,Center for Diabetes, Metabolism and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Toho University Medical Center Sakura Hospital,Center for Diabetes, Metabolism and Endocrinology
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
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
| 2017 | Year | 03 | Month | 31 | 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 | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030580
