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

This study is currently recruiting participants.
Verified October 2017 by Julie Killerup Kaae, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03302676
First Posted: October 5, 2017
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Danish Cancer Society
OPEN - Odense Patient data Explorative Network
Information provided by (Responsible Party):
Julie Killerup Kaae, Odense University Hospital
  Purpose
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.

Condition Intervention Phase
Head and Neck Cancer Radiation Therapy Complication Xerostomia Hyposalivation Dietary Supplement: Chewing gum Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Julie Killerup Kaae, Odense University Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 210
Actual Study Start Date: September 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Julie K Kaae, MD +45 22314498 julie.killerup.kaae@rsyd.dk
Contact: Jesper G Eriksen, Professor jesper@oncology.au.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Danmark, Denmark, 5000
Contact: Julie K Kaae, MD    22314498    julie.killerup.kaae@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Danish Cancer Society
OPEN - Odense Patient data Explorative Network
Investigators
Principal Investigator: Julie K Kaae, MD Odense University Hospital
  More Information

Responsible Party: Julie Killerup Kaae, M.D., Odense University Hospital
ClinicalTrials.gov Identifier: NCT03302676     History of Changes
Other Study ID Numbers: S-20160053
First Submitted: October 2, 2017
First Posted: October 5, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Julie Killerup Kaae, Odense University Hospital:
Saliva substitute

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases