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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002933
Receipt No. 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

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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
Email

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
Email hifu0125@dpc.aichi-gakuin.ac.jp

Sponsor
Institute Department of Maxillofacial Surgery, Aichi-Gakuin University School of Dentistry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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