Clinical trial · Interventional
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
NCT01663246CI-TRIAL-00015398completedN/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)
The investigators are conducting research about oral health and saliva to find out more about the impact of radiation therapy on the oral health of patients. In order to better understand the role of saliva in maintaining oral health in these patients, the investigators will be collecting, storing, and analyzing the quality of saliva, including the protein content, collected from patients following radiation therapy as well as saliva collected from normal healthy adults.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Saliva Sample | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Healthy Adults
- description
- Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.
- interventionNames
- Procedure: Saliva Sample
- type
- ACTIVE_COMPARATOR
- label
- Radiation for Head and Neck Cancer
- description
- History of radiation therapy for head and neck cancer.
- interventionNames
- Procedure: Saliva Sample
Primary outcomes (2)
- measure
- prevalence of dental caries in patients after PS-IMRT
- timeFrame
- 24 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects who have been enrolled in a parotid-sparing IMRT protocol for head and neck cancer at University of Michigan. * At least 6 months has elapsed since the completion of RT, at the time of assessment for this study. * All subjects must sign a University of Michigan Health System- IRB approved informed consent. * Documented Karnofsky performance status \> 60 * These subjects will all have American Joint Committee on Cancer (AJCC) Stage III or Stage IV disease. (Green et al, 2001) (Appendix 2); non-metastatic, curable disease Exclusion Criteria: * History of surgical removal of major salivary gland(s). * Patients edentulous prior to radiation therapy. * Pregnancy or lactation * Patients residing in prison. * Age\< 18 years.
References
Publications (0)
Data not yet available
No reference posted for this study.