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

NCT02870270 | Completed

• 1 other identifier: 682-07
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Mouth Diseases; Quality of Life; Secretion; Salivary Gland, Deficient

Keywords

saliva; microflora; diet; quality of life; oral cancer

Outcome Measures

Primary Outcomes (1)

• Changes in salivary secretion rate

  Pretreatment- two years post treatment

Secondary Outcomes (1)

• Changes in oral microflora

  Pretreatment- two years post treatment

Study Arms (1)

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

Interventions

Cancer treatment OTHER

Patients undergoing treatment for cancer in the head and neck region

Head and neck cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• or more own teeth
• No removable prosthesis
• No dental implants consisting of more than one tooth
• Able to read and understand Swedish

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Göteborg University: lead
• The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland: collaborator

Study Sites (1)

Institute of odontology

Gothenburg, 41390, Sweden

Location

Related Publications (1)

• Almstahl A, Alstad T, Fagerberg-Mohlin B, Carlen A, Finizia C. Explorative study on quality of life in relation to salivary secretion rate in patients with head and neck cancer treated with radiotherapy. Head Neck. 2016 May;38(5):782-91. doi: 10.1002/hed.23964. Epub 2015 Jun 20.

  PMID: 25537660 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Minor salivary gland secretion, stimulated whole saliva

MeSH Terms

Conditions

Mouth Diseases; Mouth Neoplasms

Interventions

Antineoplastic Protocols

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Clinical Protocols; Therapeutics; Drug Therapy; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Annica Almståhl, Assoc. prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: January 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)