Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upp… (NCT00016380) | Clinical Trial Compass
CompletedPhase 3
Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen
Canada211 participantsStarted 2001-02-28
Plain-language summary
RATIONALE: Antiemetic drugs may help to reduce or prevent vomiting in patients treated with radiation therapy. It is not yet known if ondansetron is more effective with or without dexamethasone in preventing vomiting caused by radiation therapy.
PURPOSE: This randomized phase III trial is comparing how well ondansetron works with or without dexamethasone in preventing vomiting in patients with cancer who are receiving radiation therapy to the upper abdomen.
Who can participate
Age range16 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Cancer patients who are scheduled to receive radiotherapy within the next 3 weeks
* Total dose at least 2,000 cGy delivered in at least 15 fractions
* 1 fraction per day, 5 days per week
* Treatment field to include an area of at least 80 cm2 in the anterior/posterior direction encompassing the upper abdomen
* At risk of developing radiation-induced emesis
* No emesis (retching and/or vomiting) or nausea with severity greater than 2 within the past week
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* No jaundice
* No moderate to severe hepatic dysfunction
Renal:
* Not specified
Gastrointestinal:
* No active peptic ulcer
* No lactose intolerance
Other:
* No concurrent condition or illness that contraindicates corticosteroids, serotonin antagonists, or prochlorperazine (e.g., diabetes mellitus)
* No prior unusual or allergic reaction to a serotonin antagonist (ondansetron, dolasetron, or granisetron), corticosteroid, or prochlorperazine
* No condition that would preclude accessibility to treatment or follow-up
* Able and willing to complete diary and quality of life questionnaires in either English or French
* Able to swallow
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 1 week since prior cytotoxic therapy
* No concurrent cytotoxic therapy
Endocrine therapy:
* No concurrent cortic…