The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
Primary Purpose
Head and Neck Cancer, Radiation Therapy Complication, Xerostomia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Chewing gum
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Saliva substitute
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
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month. Daily registrations in a patient dairy.
Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03302676
First Posted
October 2, 2017
Last Updated
March 12, 2019
Sponsor
Odense University Hospital
Collaborators
Danish Cancer Society, Odense Patient Data Explorative Network
1. Study Identification
Unique Protocol Identification Number
NCT03302676
Brief Title
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
Official Title
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Danish Cancer Society, Odense Patient Data Explorative Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Radiation Therapy Complication, Xerostomia, Hyposalivation
Keywords
Saliva substitute
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:1 randomization in favor of chewing gum (intervention)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month.
Daily registrations in a patient dairy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chewing gum
Primary Outcome Measure Information:
Title
Salivary flow (intervention arm)
Description
Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Salivary flow (both groups of patients)
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie K Kaae, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Danmark
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31606226
Citation
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.
Results Reference
derived
Learn more about this trial
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
We'll reach out to this number within 24 hrs