Home » Trials » SLCTR/2017/040
Effectiveness of an intervention to improve health and oral health related quality of life of oral cancer patients who receive radiotherapy with or without chemotherapy in a tertiary referral centre in Sri Lanka
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SLCTR Registration Number
SLCTR/2017/040
Date of Registration
The date of last modification
Jul 19, 2019
Scientific Title of Trial
Effectiveness of an intervention to improve health and oral health related quality of life of oral cancer patients who receive radiotherapy with or without chemotherapy in a tertiary referral centre in Sri Lanka
Public Title of Trial
Effectiveness of an intervention to improve health and oral health related quality of life of oral cancer patients who receive radiotherapy with or without chemotherapy in a tertiary referral centre in Sri Lanka
Disease or Health Condition(s) Studied
Oral cancer patients who receive radiotherapy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1201-4588
Any other number(s) assigned to the trial and issuing authority
EC-17-133 (ERC: Colombo)
What is the research question being addressed?
What is the effectiveness of an intervention to improve oral health in patients with oral cancer before radiotherapy when compared to historical controls?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Historical
Assignment
Other
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Dental assessment will be done in the dental clinic at the study hospital by the PI using sterilized mouth mirror and a probe and will be recorded in the intra-oral examination sheet. All treatments will be done using sterilized instruments.
The patient and the caregiver will be given individual education on oral hygiene before, during and after cancer treatment and provided a leaflet containing necessary information.
The treatments may include following procedures based on standard guidelines - Scaling - Fillings - Existing sharp teeth and restorations will be adjusted - Fluoride varnish application - All teeth with a questionable prognosis will be extracted. As the treatment of choice, teeth with pulpally involved carious lesions, peri-apical pathology and advanced periodontal disease will be removed (minimum of 10 days prior to commencement of cancer treatments. - Antibiotics will be prescribed in accordance with locally agreed guidelines.
During treatment intervention: Careful monitoring of oral health especially important during cancer therapy to prevent, detect and treat complications as soon as possible.
- Review oral hygiene (oral examination) once a week during radiotherapy. Advice and treat patient accordingly.
- For fungal infections - advice to apply miconazole oral gel four times daily
- For dry mouth -sipping water, moistening the oral cavity, use of artificial saliva
- Use of mouth rinses - Baking soda and salt mouthwash
- To prevent trismus - stretching exercises
After treatment intervention: - Review oral hygiene every month for three months and provide necessary medical advice and treatments.
The control group will be a matching cohort of patients who have been previously assessed on the study outcomes at the designated time points.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Oral health related quality of life and health related quality of life as determined by the following 1) Modified EORTC-OH15 questionnaire (European Organisation for the Research and Treatment-Oral Health15) 2) Modified EORTC C-30 (Core 30) questionnaire 3) Modified EORTC H&N35 (Head & Neck 35) questionnaire |
[ At baseline, during last week of radiotherapy course and 3 months after completion of radiotherapy. ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
84 (42 in the intervention arm and 42 historical controls)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-12-06
Anticipated end date
2018-04-30
Date of first enrollment
2017-12-07
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-11-16
Approval number
EC-17-133
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. K.M.S.H. Kosgallana
Registrar in Community Dentistry
Institute of Oral Health, Maharagama, Sri Lanka
0777684765
shaminikos@gmail.com
Contact Person for Public Queries
1.Dr.J.L.P.Jayasekara 2.Dr.Prasad Abeysinghe
1.Consultant in Community Dentistry 2. Consutant oncologist
(1) National Cancer Control Programme, 555/5, Public Health Complex, Elvitigala Mawatha,
Colombo 05, Sri Lanka
(2) Apeksha Hospital, Maharagama
(1) 0112368627 (2) 0112850253
jayasekara_prasanna@yahoo.com
Primary study sponsor/organization
Apeksha Hospital
National Cancer Institute of Sri Lanka
Maharagama, Sri Lanka
Tel: +94-011-2850253
Fax: +94-011-2842051
info@ncisl.health.gov.lk
www.ncisl.health.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
