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 range

18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00017511

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-03

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