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