The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
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|ClinicalTrials.gov Identifier: NCT03302676|
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Radiation Therapy Complication Xerostomia Hyposalivation||Dietary Supplement: Chewing gum||Phase 3|
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.
- 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2:1 randomization in favor of chewing gum (intervention)|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||January 2019|
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.
- 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.
- Salivary flow (both groups of patients) [ Time Frame: 1 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302676
|Contact: Julie K Kaae, MD||+45 firstname.lastname@example.org|
|Contact: Jesper G Eriksen, Professoremail@example.com|
|Odense University Hospital||Recruiting|
|Odense, Danmark, Denmark, 5000|
|Contact: Julie K Kaae, MD 22314498 firstname.lastname@example.org|
|Principal Investigator:||Julie K Kaae, MD||Odense University Hospital|