Clinical trial · Interventional
Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
To Evaluate the Effects of Transfer of Submandibular Salivary Gland to the Submental Region (Outside the Radiation Field) on Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
- 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)
The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation alone | Procedure | — | UNRESOLVED |
| radiation treatment and surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quality of life
Secondary outcomes (7)
- measure
- Treatment interruptions
- measure
- Incidence of percutaneous endoscopic gastronomy (PEG)
- measure
- Incidence of oral candidiasis
- measure
- Overall survival
- measure
- Disease free survival
- measure
- Pattern of recurrence
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a histological diagnosis of squamous cell carcinoma * Patients with unilateral or no neck involvement of the nasopharynx * The submandibular transfer will be done on the uninvolved side of the neck. * Karnofsky score greater than or equal to 70 * Expected survival greater than one year * A signed informed consent Exclusion Criteria: * Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.
References
Publications (0)
Data not yet available