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Prospective Studies on Oral Health and Quality of Life in Head and Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT02870270
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : August 19, 2016
Sponsor:
Collaborator:
The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

Radiation therapy (RT) leads to a markedly reduced salivary secretion rate, which makes it difficult to eat and talk and it is a risk factor for oral disorders such as caries and mucosal infections. A reduced salivary secretion rate is often a life long side-effect of the treatment that seriously affect the quality of life. To reduce these side-effects the patients get preventive and supportive oral treatment in connection with their cancer treatment. However, regardless of radiation doses given, the severity of the problems vary considerably. Therefore, a better understanding on when and why problems occur is important for the identification of subjects at risk and to find better measures and treatments, suited for their individual needs.

Dentate subjects were included referred before RT. Data were collected before and during treatment as well as 6, 12 and 24 months after completed RT. Cancer diagnosis, treatment, radiation doses, infections and medication were obtained from medical records.

Dietary habits were registered using a questionnaire focusing on intake of carbohydrate-rich food-items and items containing sugar-substitutes. The subjects weight was registered before, during and after RT.

A clinical examination was performed before and 6, 12 and 24 months after completed RT. Panoramic x-rays were taken as well as bitewing radiographs. The number of teeth, caries status, oral hygiene were registered. Mucositis was registered during RT.

Secretion of stimulated whole saliva was determined. Minor labial and buccal gland saliva secretion rate was determined using the Periotron-method. Microbial samples were collected from the tongue, buccal mucosa and supragingival plaque and microorganisms associated with oral health and oral disorders analysed using cultivation technique.

The quality of life was registered using the questionnaires EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire). To address additional symptoms associated specifically with cancer in the head and neck region and its treatment, a complementary 35-item module, the EORTC QLQ-H&N35 was used.

The patients also completed the Hospital Anxiety and Depression Scales, HADS, which is used to measure severity of anxiety and depressive symptoms and provides estimates of possible mood disorders in patients with somatic comorbidity.


Condition or disease Intervention/treatment
Mouth Diseases Quality of Life Secretion; Salivary Gland, Deficient Other: Cancer treatment

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Studies on Saliva, Microflora, Diet, Oral Status and Quality of Life in Subjects Undergoing Radiation Therapy in the Head and Neck Region
Study Start Date : January 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


Group/Cohort Intervention/treatment
Head and neck cancer patients
Patients with head and neck cancer who were ≥ 18 years old and had ≥ 16 teeth and no removable prosthesis or dental implants consisting of more than one teeth were included
Other: Cancer treatment
Patients undergoing treatment for cancer in the head and neck region




Primary Outcome Measures :
  1. Changes in salivary secretion rate [ Time Frame: Pretreatment- two years post treatment ]

Secondary Outcome Measures :
  1. Changes in oral microflora [ Time Frame: Pretreatment- two years post treatment ]

Biospecimen Retention:   Samples With DNA
Minor salivary gland secretion, stimulated whole saliva


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were diagnosed with cancer in the head and neck region and were treated with curative radiotherapy at Sahlgrenska university hospital, Gothenburg, Sweden.
Criteria

Inclusion Criteria:

18 years or older

16 or more own teeth

No removable prosthesis

No dental implants consisting of more than one tooth

Able to read and understand Swedish

Exclusion Criteria:

< 18 years old

< 16 teeth

Removable prosthesis

Dental implants consisting of more than one tooth

Severe cognitive impairment

Unable to read and/or understand Swedish


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870270


Locations
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Sweden
Institute of odontology
Gothenburg, Sweden, 41390
Sponsors and Collaborators
Göteborg University
The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland
Investigators
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Principal Investigator: Annica Almståhl, Assoc. prof Göteborg University

Publications of Results:
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02870270     History of Changes
Other Study ID Numbers: 682-07
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Göteborg University:
saliva
microflora
diet
quality of life
oral cancer

Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases