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Trial registered on ANZCTR


Registration number
ACTRN12612000637842
Ethics application status
Approved
Date submitted
14/06/2012
Date registered
15/06/2012
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact evaluation of a dental care program in the quality of life of head and neck cancer patients.
Scientific title
Randomized clinical trial to evaluate the impact of a dental care program in the quality of life of head and neck cancer patients.
Secondary ID [1] 280631 0
'Nil"
Universal Trial Number (UTN)
U1111-1130-6027
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer. 286642 0
Prevention of oral conditions. 286706 0
Condition category
Condition code
Cancer 286926 286926 0 0
Head and neck
Oral and Gastrointestinal 286943 286943 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group received a dental care program including pain relief, extractions, periodontal treatment, restorations, topical fluoride, endodontics, prevention and oral higyene and a systematic professional follow up. Invasive dental treatment was considered as a priority and was carried out whenever possible as soon as the patient is considered eligible for the study, and before the beggining of the oncological therapy. Dental treatment was continued during and after oncological therapy at the institution. Depending on the needs assessed by the dentist and availability of services in the institution, each participant received a basic set of preventive and education measures, as well as a specific set of dental treatment. The frequency of dental care varied according to the needs of the subjects. The last appointment was offered up to six months after the end of the oncological treatment.
Intervention code [1] 285027 0
Prevention
Intervention code [2] 285086 0
Treatment: Other
Comparator / control treatment
The control group received basic oral health care (pain relief, preventive measures, and oral higyene instructions) prior the onclogical treatment and was referred to primary care services for dental care.
Control group
Active

Outcomes
Primary outcome [1] 287291 0
Quality of Life: measured by WHOQOL-BREF.
Timepoint [1] 287291 0
15 days after the conclusion of the oncological treatment.
Primary outcome [2] 287335 0
Specific Quality of Life: measured by EORTC-QLQ H&N 35.
Timepoint [2] 287335 0
15 days after the conclusion of the oncological treatment.
Secondary outcome [1] 297843 0
1- Candidiasis: clinical examination
Timepoint [1] 297843 0
Before and 15 days after oncological treatment
Secondary outcome [2] 297844 0
2- Xerostomia: clinical examination
Timepoint [2] 297844 0
Before and 15 days after oncological treatment
Secondary outcome [3] 297845 0
3- Osteoradionecrosis: clinical examination
Timepoint [3] 297845 0
Before and 15 days after oncological treatment
Secondary outcome [4] 297846 0
4- Trismus: clinical examination
Timepoint [4] 297846 0
Before and 15 days after oncological treatment
Secondary outcome [5] 297847 0
5- Taste alteration: it was assessed by means of one clinical question to the subject
Timepoint [5] 297847 0
Before and 15 days after oncological treatment

Eligibility
Key inclusion criteria
Patients with primary cancer located in the head and neck and without previous oncological treatment and also having clinical conditions to get dental treatment. Any histological type was accepted.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previous oncological treatment and those who did not accepted to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation concealment was made using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used was a simple randomization by using a randomization table from a statistic book until completing the elegible sample size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4350 0
Brazil
State/province [1] 4350 0
RS

Funding & Sponsors
Funding source category [1] 285407 0
Government body
Name [1] 285407 0
Brazilian National Research Council and Scientific Development-CNPq
Address [1] 285407 0
SHIS QI 01 Conjunto B Bloco B CNPq
CEP 71605-170
Brasilia DF
Country [1] 285407 0
Brazil
Primary sponsor type
University
Name
Federal University of Rio Grande do Sul
Address
Rua Ramiro Barcelos 2491
Departamento de ODontologia Preventiva e Social
3o. Andar.
CEP 90035-000
Porto Alegre - RS
Country
Brazil
Secondary sponsor category [1] 284259 0
Government body
Name [1] 284259 0
Gerencia de Ensino e Pesquisa do Grupo Hospitalar Conceicao - Ministry of Health
Address [1] 284259 0
Rua Francisco Trein 596
3.o Andar
91350-200
Porto Alegre - RS
Country [1] 284259 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287417 0
Comite de Etica em Pesquisa do Grupo Hospitalar Conceicao
Ethics committee address [1] 287417 0
Rua Francisco Trein 596
Gerencia de Ensino e PEsquisa
3o. Andar
CEP 91350-200
Porto Alegre - RS
Ethics committee country [1] 287417 0
Brazil
Date submitted for ethics approval [1] 287417 0
Approval date [1] 287417 0
23/05/2006
Ethics approval number [1] 287417 0
Ethics committee name [2] 287418 0
Comite de Etica em Pesquisa da Universidade Federal do RGS
Ethics committee address [2] 287418 0
Rua Ramiro Barcelos 2492
CEP 90035-00
Porto Alegre - RS
Ethics committee country [2] 287418 0
Brazil
Date submitted for ethics approval [2] 287418 0
Approval date [2] 287418 0
13/06/2006
Ethics approval number [2] 287418 0

Summary
Brief summary
The aim of the study is to verify the efficacy of a dental care programe on the quality of life of head and neck cancer patients under oncological treatment at the Hospital Nossa Senhora da Conceicao, Porto Alegre - Brazil.
The hypothesis was that dental care could minimize the oncological treatment side effects and also could improve the quality of life of the patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34278 0
Address 34278 0
Country 34278 0
Phone 34278 0
Fax 34278 0
Email 34278 0
Contact person for public queries
Name 17525 0
Julio Baldisserotto
Address 17525 0
Rua Francisco Trein 596
CEP 91350-200
Porto Alegre - RS - Brazil
Country 17525 0
Brazil
Phone 17525 0
55-51-33572575
Fax 17525 0
Email 17525 0
bjulio@ghc.com.br
Contact person for scientific queries
Name 8453 0
Julio Baldisserotto
Address 8453 0
Rua Francisco Trein 596
CEP 91350-200
Porto Alegre - RS - Brazil
Country 8453 0
Brazil
Phone 8453 0
55-51-33572575
Fax 8453 0
Email 8453 0
bjulio@ghc.com.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary