UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050011 |
|---|---|
| Receipt number | R000056700 |
| Scientific Title | Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2023/01/11 11:43:31 |
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Basic information
Public title
Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study
Acronym
Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study
Scientific Title
Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study
Scientific Title:Acronym
Efficacy and safety of HMB/Gln/Arg for the prophylaxis of chemoradiation -induced mucositis in head and neck squamous cell carcinoma: Randomized Phase II Clinical Study
Region
| Japan |
Condition
Condition
Head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of Abound for the chemoradiation-induced mucositis in patients with head and neck squamous cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of more than grade 3 mucositis
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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administe HMB/Arg/Gln to patients who undergo cis-platinum CRT
Interventions/Control_2
patients who undergo cis-platinum CRT.
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
Inclusion criteria were historically diagnosed HNSCC arising in nasopharynx, oropharynx, hypopharynx or larynx; age of 20-75years; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; subject to more than 60Gy of platinum based CRT; and normal findings in pretreatment swallowing videofluorography.
Key exclusion criteria
Exclusion criteria were T4 larynx or hypopharynx; T1-2 glottic larynx; and previous history of irradiation in the head and neck.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Muneyuki |
| Middle name | |
| Last name | Masuda |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Dept. of Head and Neck Surgery
Zip code
811-1395
Address
Notame, Minamiku, Fukuoka
TEL
092-541-3231
mmuneyuki@icloud.com
Public contact
Name of contact person
| 1st name | Muneyuki |
| Middle name | |
| Last name | Masuda |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Head and Neck Surgery
Zip code
811-1395
Address
3-1-1, Notame, Minamiku, Fukuoka
TEL
092-541-3231
Homepage URL
mmuneyuki@icloud.com
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Sota memorial fund
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center
Address
3-1-1, Notame, Minamiku, Fukuoka 811-1395 Japan
Tel
092-541-3231
mmuneyuki@icloud.com
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
| 2023 | Year | 01 | Month | 11 | 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
75
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056700
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