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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Xerostomia; Hyposalivation; Radiation Therapy Complication
• Intervention / Treatment: Dietary supplement: Chewing gum

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Odense, Danmark, Denmark, 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month. Daily registrations in a patient dairy.	Dietary supplement: Chewing gum
No Intervention: Control; Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary flow (intervention arm)	Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary flow (both groups of patients)	The difference between unstimulated and stimulated salivary flow will be higher for patients in the intervention arm as compared to the difference in salivary flow for patients in the control arm.	1 month

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Danish Cancer Society; Odense Patient Data Explorative Network
• Investigators: Principal Investigator: Julie K Kaae, MD, Odense University Hospital

Publications and helpful links

General Publications

• Kaae JK, Stenfeldt L, Hyrup B, Brink C, Eriksen JG. A randomized phase III trial for alleviating radiation-induced xerostomia with chewing gum. Radiother Oncol. 2020 Jan;142:72-78. doi: 10.1016/j.radonc.2019.09.013. Epub 2019 Oct 9.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Saliva substitute
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Salivary Gland Diseases; Oropharyngeal Neoplasms; Xerostomia
• Other Study ID Numbers: S-20160053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No