UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002933 |
|---|---|
| Receipt number | R000003568 |
| Scientific Title | A multi-centre trial for the treatment of oral leukoplakia with the aid of chemopreventive agents |
| Date of disclosure of the study information | 2009/12/23 |
| Last modified on | 2009/12/23 16:00:16 |
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Basic information
Public title
A multi-centre trial for the treatment of oral leukoplakia with the aid of chemopreventive agents
Acronym
Chemoprevention of oral leukoplakia
Scientific Title
A multi-centre trial for the treatment of oral leukoplakia with the aid of chemopreventive agents
Scientific Title:Acronym
Chemoprevention of oral leukoplakia
Region
| Japan |
Condition
Condition
Oral leukoplakia
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of low-dose beta-carotene with vitamin C supplements for the treatment and against malignant transformation of oral leukoplakia among non-smokers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical remission
Key secondary outcomes
Likelihood of malignant transformation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
One year supplement of 5mg 2 times/day of beta-carotene and 250mg 2 times/day of vitamin C
Interventions/Control_2
One year supplement of 25mg 2 times/day of vitamin C
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Predominantly white lesion of oral mucosa clinically diagnosed as leukoplakia based on the WHO criteria and confirmed histologically
2) Both non-dysplastic and those with mild to moderate dysplasia histo-pathologically
3) Non-smokers or ex-smokers more than 3 months
4) Discontinuing to take any over the counter micronutrient supplements 4 weeks prior to entering the trial
Key exclusion criteria
1) Any other specific disorders that could appear as a white lesion such as frictional keratosis, hairly leukoplakia, leukoedema, oral lichen planus and erythroplakia
2) Severe dysplasia, carcinoma in situ or micro-invasive carcinoma
3) Current smokers
4) Having adverse medical problems
5) Pregnancy
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nagao |
Organization
Aichi-Gakuin University School of Dentistry
Division name
Department of Maxillofacial Surgery
Zip code
Address
2-11,Suemori-dori,Chikusa-ku, Nagoya 464-8651,Japan
TEL
052-759-2160
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Fukano |
Organization
Chemoprevention Study Group for Oral Leukoplakia
Division name
Department of Maxillofacial Surgery, Aichi-Gakuin University School of Dentistry
Zip code
Address
2-11,Suemori-dori,Chikusa-ku, Nagoya 464-8651,Japan
TEL
052-759-2160
Homepage URL
hifu0125@dpc.aichi-gakuin.ac.jp
Sponsor or person
Institute
Department of Maxillofacial Surgery, Aichi-Gakuin University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Great Britain Sasakawa Foundation, UK
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
UK
Other related organizations
Co-sponsor
Department of Oral Medicine, WHO Collaborating Centre for Oral Cancer Precancer,King's College Dental Institute at Guy's,King's&St.Thomas' Hospitals London,UK
Name of secondary funder(s)
DSM Nutrition Japan
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
愛知学院大学歯学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The overall clinical response rate in the experimental arm (low dose of beta-carotene and vitamin C) was 17.4% and 4.3% in the placebo arm (P=0.346). During the follow-up period (median 60 months), two subjects in the experimental arm and three subjects in the control arm developed oral cancer. The relative risk for supplementing with beta-carotene and vitamin C was 0.77 (95%CI: 0.28-1.89) (P=0.580) by the Cox proportional hazards model. No untoward side effects have been noted.
The supplemental low dose of beta-carotene and vitamin C for oral leukoplakia among non-smokers were neither effective for clinical remission nor for protection against cancer development statistically.
(The Annual Conference of the British Association of Oral Surgeons ,December 2009, Birmingham,UK)
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
| 2000 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 23 | Day |
Last modified on
| 2009 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003568
