UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010370 |
|---|---|
| Receipt number | R000012135 |
| Scientific Title | Phase II study on reduction of mucous membrane inflammation by the nutritional supplement Elental in concurrent chemoradiotherapy for head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/04/24 10:13:31 |
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Basic information
Public title
Phase II study on reduction of mucous membrane inflammation by the nutritional supplement Elental in concurrent chemoradiotherapy for head and neck squamous cell carcinoma
Acronym
Reduction of mucous membrane inflammation by Elental in concurrent chemoradiotherapy
Scientific Title
Phase II study on reduction of mucous membrane inflammation by the nutritional supplement Elental in concurrent chemoradiotherapy for head and neck squamous cell carcinoma
Scientific Title:Acronym
Reduction of mucous membrane inflammation by Elental in concurrent chemoradiotherapy
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Concurrent chemoradiotherapy (CCRT) is effective in treating head and neck cancer, but adverse effects, ie, inflammation of oral and pharyngeal mucosa, are common. A treatment to prevent such inflammation during CCRT has not been established.
The nutritional supplement "Medicine Combined With Elental" (hereafter Elental) inhibits mucous membrane inflammation via the action of amino acids (ie, glutamine, histidine), and may thus be useful in reducing such inflammation during cancer treatment. We examined the effect of Elental on oral/pharyngeal mucosal inflammation during CCRT for head and neck cancer.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
CTCAE score for inflammation of oral/pharyngeal mucosa
Key secondary outcomes
Rate of CCRT completion, duration of cessation of oral-intake, duration and dosage of opioids, days of Elental administration, days of hospitalization after CCRT, body weight, total protein, albumin decrease (%)
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 considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elental (1 pack per day) from day 1 to 7 days after end of radiation therapy
Interventions/Control_2
No administration of Elental
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) Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical CCRT, ie, 3 courses of CDDP every 3 weeks plus whole-neck irradiation, including bilateral levels II-IV
2) Initial chemotherapy
3) Measurable or evaluable lesions
4) Performance status (PS) 0-1
5) Age 20-75 years
6) No complications that might affect treatment
7) No other cancer
8) Normal liver, kidney, and marrow function
White blood cells >3,000/mm3
Neutrophils >1,500/mm3
Blood platelet >100,000mm3
Total bilirubin normal
AST and ALT normal
Creatinine normal
Ccr or eGFR >60 ml/min
9) Written informed consent
Key exclusion criteria
1) Past history of serious drug hypersensitivity
2) Presence of other cancer
3) Clinically problematic infectious disease
4) >1 complication that might affect treatment
5) Nonradical treatment indicated
6) Pregnant or nursing women and those with the possibility of pregnancy
7) Mental or neurologic disease that might affect participation
8) Abnormality in amino acid metabolism
9) Severe diabetes or possibility of glucose metabolism abnormality due to high-dose steroid treatment
10) Participation judged by physician to be inadvisable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsuyama |
Organization
Niigata University, Faculty of Medicine
Division name
Otolaryngology, Head and Neck
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL
+81-25-227-2306
matsuhiroshi@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsuyama |
Organization
Niigata University, Faculty of Medicine
Division name
Otolaryngology, Head and Neck
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL
+81-25-227-2306
Homepage URL
matsuhiroshi@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata Cancer Center Hospital
Niigata City General Hospital
Nagaoka Red Cross Hospital
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
新潟大学医歯学総合病院（新潟県）
新潟県立がんセンター新潟病院（新潟県）
新潟市民病院（新潟県）
長岡赤十字病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012135
