Clinical trial · Interventional
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cevimeline in the Treatment of Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region
NCT00017511CI-TRIAL-00006939completedPhase 3ClinicalTrials.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)
RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.
Conditions
Conditions (3)
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 |
| Oral Complications | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cevimeline hydrochloride | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region * Radiotherapy completed more than 4 months prior to study * Clinically significant salivary gland dysfunction with grade 2 or 3 xerostomia * At least 1 anatomically intact parotid gland * No suspected or confirmed bilateral physical closure of salivary gland ducts * No history of primary or secondary Sjogren's syndrome or other underlying systemic illness known to cause xerostomia independent of prior radiotherapy exposure PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% * ECOG 0-2 Life expectancy: * At least 6 months Hematopoietic: * Hemoglobin at least 9.0 g/dL * No anemia Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT/SGPT no greater than 2 times ULN * Lactate dehydrogenase no greater than 2 times ULN * No evidence of active liver disease Renal: * Creatinine no greater than 2.5 mg/dL * BUN no greater than 50 mg/dL * No history of nephrolithiasis within the past 6 months Cardiovascular: * No history of significant cardiovascular disease * No active congestive heart failure * No uncontrolled angina * No significant arrhythmia * No myocardial infarction within the past 6 months Pulmonary: * No history of significant pulmonary disease * No controlled or uncontrolled asthma * No chronic bronchitis or chronic obstructive pulmonary disease that would limit avocational activities Gastrointestinal: * No history of significant gastrointestinal disorder * No active pancreatic disease * No gastroduodenal ulcers within the past 6 months * No hypersensitive bowel conditions requiring pharmacologic therapy * No inflammatory bowel disease * No history of cholelithiasis within the past 6 months (unless cholecystectomy performed) Other: * No clinically significant laboratory abnormality * No history of alcohol or drug abuse within the past 6 months that would preclude study * No prior or concurrent acute iritis or narrow-angle (angle closure) glaucoma * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * Not specified Other: * At least 30 days since other investigational new drug * At least 4 weeks since prior systemic or ophthalmic pilocarpine * No prior cevimeline * No concurrent hyperbaric oxygen therapy * No concurrent beta adrenergic antagonists, anticholinergic agents, cevimeline metabolism inhibitors, or other medications known to effect salivary function * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.