Clinical trial · Interventional
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
NCT03302676CI-TRIAL-00037614completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hyposalivation | — | UNRESOLVED | — |
| Radiation Therapy Complication | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chewing gum | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- description
- Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month. Daily registrations in a patient dairy.
- interventionNames
- Dietary Supplement: Chewing gum
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.
Primary outcomes (1)
- measure
- Salivary flow (intervention arm)
- timeFrame
- 1 month
- description
- Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKaae 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. PMID 31606226