UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022709
Receipt number R000026165
Scientific Title Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.
Date of disclosure of the study information 2016/06/13
Last modified on 2023/12/19 09:35:21

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Basic information

Public title

Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.

Acronym

Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.

Scientific Title

Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.

Scientific Title:Acronym

Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.

Region

Japan


Condition

Condition

Oral cancer

Classification by specialty

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of amino acids supplementation on the severity of mucositis and other adverse events during chemoradiotherapy in oral cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The severity of mucositis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Test foods containing of amino acids is administered by orally or gavage, twice daily (morning and evening) from the start day of the chemotherapy to 14 days after the chemoradiotherapy.

Interventions/Control_2

Placebo is administered by orally or gavage, twice daily (morning and evening) from the start day of the chemotherapy to 14 days after the chemoradiotherapy

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) Patients (men and women aged from 20 to 90 years old) undergo chemoradiotherapy as preoperative treatment
2) Patients from whom written informed consent is obtained
3) Patients deemed suitable by the principal investigator, investigators of the research project or investigators of the sub institution.

Key exclusion criteria

1) Patients who have the severe complications
2) Patients who have the history of severe hypersensitivity
3) Patients who have the history of aminoacidopathy
4) Patients included in other clinical studies within 3 months or in process.
5) Patients with other conditions whom principal investigator, the investigator of this project and the investigator of sub institution consider inadequate such as routine users of similar food (e.g. amino acid supplement)
6) Patients who have renal dysfunction that creatinine clearance are less than 30 ml/min

Target sample size

52


Research contact person

Name of lead principal investigator

1st name Seiji
Middle name
Last name Nakamura

Organization

Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University

Division name

Section of Oral and Maxillofacial Oncology

Zip code

812-8582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan

TEL

092-642-6447

Email

seiji@dent.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Kazunari
Middle name
Last name Oobu

Organization

Kyushu University Hospital

Division name

Department of Oral Surgery

Zip code

812-8582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan

TEL

092-642-6447

Homepage URL


Email

kazunari@dent.kyushu-u.ac.jp


Sponsor or person

Institute

KYOWA HAKKO BIO CO., LTD

Institute

Department

Personal name



Funding Source

Organization

KYOWA HAKKO BIO 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

Ethics committee of Kyushu University Hospital

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan

Tel

092-642-5774

Email

byskenkyu@jimu.kyushu-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

九州大学病院(福岡県)、鹿児島大学医学部・歯学部附属病院(鹿児島県)


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 13 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

2016 Year 04 Month 29 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 30 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 06 Month 12 Day

Last modified on

2023 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026165


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name