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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 -

SLCTR Registration Number

SLCTR/2017/040


Date of Registration

06 Dec 2017

The date of last modification

Dec 06, 2017



Application Summary


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 of Health Condition(s) Studied

Oral cancer patients who receive radiotherapy


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1201-4588


Any other number(s) assigned to the trial and issuing authority

EC-17-133 (ERC: Colombo)


Trial Details


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


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

  1. Male and female patients aged 18 years and above
  2. Biopsy confirmed patients with oral cancer patients with any stage of disease
  3. Newly diagnosed (< 3 months) and awaiting radiotherapy (with or without chemotherapy) as the initial treatment
  4. Sufficient language ability in Sinhala to understand and complete the questionnaires
  5. Not participating in any other trial or study possibly interfering with the present study

Exclusion criteria

  1. Patients who have already undergone surgical treatment
  2. Patients who receive small doses of radiation therapy as palliative care
  3. Patients who are unable to participate in the interviews due to obvious cognitive impairment, psychological disturbance or language problems
  4. Patients with communication barriers and patients who wish to be followed up at private sector
  5. Patients with evidence of brain metastases


Primary outcome(s)

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


Primary outcome(s) - Time of assessment(s)

At baseline, during last week of radiotherapy course and 3 months after completion of radiotherapy.


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethical Review Committee of Faculty of Medicine University of Colombo on 20th November 2017 (Ref EC-17-133)


Funding source

None (Investigator funded)



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None