Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer (NCT00017511) | Clinical Trial Compass
CompletedPhase 3
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
United StatesStarted 2001-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 avocat…