UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024045 |
|---|---|
| Receipt number | R000027690 |
| Scientific Title | The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer. |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2016/09/14 09:13:53 |
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Basic information
Public title
The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer.
Acronym
The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer.
Scientific Title
The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer.
Scientific Title:Acronym
The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer.
Region
| Japan |
Condition
Condition
Head and neck cancer.
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of efficacy of enteral supplementation product enriched with L-glutamine in patients with head and neck cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CTCAE score for inflammation of oral pharyngeal mucosa.
Key secondary outcomes
1)Physical measurement
Body weight, Lean body weight, body fat mass, Grip strength
2)Digestive symptom
oral mucositis, taste disturbance, diarrhea, appetite
3)score of Quality of life(QOL)
EORT-QLQ-C30
4)Blood test
Alb,TP,PA,RBP,serum diamine oxidase activity,IL-6,active ghrelin
5)Amount of total Energy
by oral feeding, enteral feeding, parenteral nutrition
6)Duration and dosage of opioid.
7)Rate of CRT completion.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
L-glutamine group: L-glutamine(1-3 pack per day) from 4days before to end of CRT.
Interventions/Control_2
Control group: Placebo(1-3 pack per day) from 4days before to end of 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged >= 20
2) Patients with head and neck cancer.
3) Patients who receive chemoradiotherapy.
4) Recovered from previous chemotherapy and radiotherapy toxicities.
5) Patients who obtained the consent.
Key exclusion criteria
1)Unable intake glutamine formulations per oral or per enteral tube.
2)major impairment of liver
3)major impairment of kidney
4)allergic to L-glutamine
5)pregnant,lactating
6)presence of other cancer under treatment.
7)severe psychosis or psychiatric symptoms
8)paticipation judged by physician to be inadvisable
9)paticipation not taking opioids
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Kurihara |
Organization
Shiga University of Medical Science Hospital
Division name
Clinical nutrition
Zip code
Address
Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL
077-548-2519
kuri@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mai Inoue |
Organization
Shiga University of Medical Science Hospital
Division name
Clinical nutrition
Zip code
Address
Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL
077-548-2519
Homepage URL
maiapril@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Aido Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 10 | 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
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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
| 2016 | Year | 09 | Month | 14 | Day |
Last modified on
| 2016 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027690
