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Clinical Trials/NCT03302676
NCT03302676
Completed
Not Applicable

The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors

Odense University Hospital1 site in 1 country109 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Odense University Hospital
Enrollment
109
Locations
1
Primary Endpoint
Salivary flow (intervention arm)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a salivary stimulant for head and neck cancer patients treated with curative intended radiotherapy.

Detailed Description

Radiation-induced xerostomia and hyposalivation are frequent side effects after completed treatment for oral and oropharyngeal cancers. This may induce eating and swallowing difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. As a consequence, quality of life is often impaired for this group of patients even after completing treatment. This study hypothesize that chewing gum can stimulate salivary flow from the residual functional salivary glands and thereby improving the patient's oral well-being. Primary endpoint: - To assess whether the difference between the unstimulated and stimulated salivary flow after a one-month period of using chewing gum will result in improved oral well-being. Secondary endpoint: * To assess if unstimulated and stimulated salivary flow differs between the two groups of patients * To evaluate changes in quality of life with EORTC QLQ H\&N-35 for patients using chewing gum * To evaluate differences in quality of life with EORTC QLQ H\&N-35 between the two groups of patients. All patients who have received curative intended treatment for oral or oropharyngeal carcinomas at the Department of Oncology, Odense University Hospital, will be invited to participate in the study. If the eligibility criteria are met the patient will be randomized 2:1 to either the intervention arm with chewing gum or the control arm with standard oral care. The study intends to include 210 patients in total. Of these, 140 patients in the intervention arm and 70 in the control arm. Recruitment to the study was initiated in September 2016 and is expected to be completed in July 2018. The duration of the study is one month from inclusion and randomization to final follow up. For all included patients, saliva samples are collected (unstimulated and stimulated sialometry) and the EORTC QLQ H\&N-35 questionnaire and a xerostomia specific questionnaire are completed. The patients in the control arm are only introduced to chewing gum at the last follow up visit. In the intervention arm, all patients are instructed to use the chewing gum on a daily basis (preferably 5 times a day) and to make notes in a patient diary to document compliance.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
January 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Killerup Kaae

M.D.

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • Over 18 years of age
  • Diagnosed with oral or oropharyngeal carcinoma
  • Received curative intended radiation therapy (primary or postoperative), 60-66Gy including concurrent chemotherapy
  • Within 6 to 60 months after radiation therapy
  • Complains of xerostomia level 1 (according to Danish Head and Neck Cancer group)
  • Written informed consent

Exclusion Criteria

  • Poor teeth condition or full set of dentures
  • Recurrence of cancer or palliative treatment

Outcomes

Primary Outcomes

Salivary flow (intervention arm)

Time Frame: 1 month

Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.

Secondary Outcomes

  • Salivary flow (both groups of patients)(1 month)

Study Sites (1)

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