An interventional study of Chewing gum in Head and Neck Cancer, Radiation Therapy Complication and Xerostomia, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Supportive care
Among 62 studies in Head and Neck Neoplasms with a site in Denmark — 13 open to participants now, 18 under way, 1 of them phase 3. Head and Neck Neoplasms · Denmark.
Among the 62 studies in Head and Neck Neoplasms with a site in Denmark, this one is the 22nd largest by enrollment of the 52 interventional ones that give a count, is one of 6 that started in 2016, is one of 26 with no phase, and was the 31st registered.
2,713 studies on the registry are indexed under Head and Neck Neoplasms; 596 are open to participants now.
Browse Head and Neck Neoplasms studies →13 of the 62 studies in Head and Neck Neoplasms with a site in Denmark are open now. Recruiting first, the newest first:
OncoZenge AB · Sites in Denmark, Germany, Norway and 1 more country
Ages 18–80
Aalborg University Hospital · Sites in Denmark
Ages 18+
University of Aarhus · Sites in Denmark
Ages 18+
Rigshospitalet, Denmark · Sites in Denmark
Ages 18+
Danish Head and Neck Cancer Group · Sites in Denmark
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
62 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 13 · Phase 3 8 · Phase 4 1
First in 2003; this study’s year is marked. 6 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 109 is above the median of 46 across 2,033 interventional studies indexed under Head and Neck Neoplasms.
Median enrollment 67 across the 52 interventional studies, 80 across the 10 observational. Of the 34 that completed or were terminated, 7 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 62 have an industry lead sponsor. The 10 most frequent:
Odense University Hospital is the lead sponsor of 480 studies on the registry; 111 are open to participants now.
Odense University Hospital has 3 studies filed under Head and Neck Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies in Head and Neck Neoplasms with a site in Denmark that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07672236Phase 3OncoZenge ABA Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer. | 2026-12-23 |
Add it to your calendar (.ics) → With an account.
Among the 62 studies in Head and Neck Neoplasms with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Secondary endpoint:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.
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.
Time frame: 1 month
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.
Time frame: 1 month
Plan to share: No
Ran from Sep 2016 to primary completion in Sep 2018, 24 months.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 24 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Chewing Gum