Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Los… (NCT01501396) | Clinical Trial Compass
WithdrawnPhase 2
Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite
0Started 2013-09
Plain-language summary
This randomized phase II trial studies the safety and efficacy of megestrol acetate given with or without mirtazapine in treating cancer patients with weight loss and loss of appetite. To date, no pharmacologic interventions have been approved by FDA to treat cancer anorexia-cachexia syndrome (CACS). Megestrol acetate has been shown to increase appetite in cancer patients. Adding mirtazapine may provide a much more effective treatment and help improve quality of life.
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.
Inclusion Criteria:
* Patient must have a histologically or cytologically confirmed solid malignancy
* Patient must be \>=18 years old.
* Patient must have shown unintentional weight loss of \>= 5% in 6 weeks dating back from time of consent or \>= 10% in 6 months dating back from time of consent
* Patient must have a poor appetite (defined as a score of =\< 14 on the Simplified Nutritional Appetite Questionnaire (SNAQ)
* Prior diagnostic or therapeutic surgery is allowed as long as the wound has fully healed, the patient has fully recovered from the procedure, and at least 4 weeks have elapsed from the procedure; for needle or core biopsy, or minimally invasive procedures such as chest tube placement, this 4-week recovery period does not apply, but the patient must have recovered fully from the procedure
* Concomitant administration of chemotherapy is permitted but not required
* Prior radiation therapy is allowed for local symptom palliation prior to the start of treatment as long as at least 2 weeks have elapsed from the procedure and the patient has fully recovered from treatment-related toxicities
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Patient must have normal organ and marrow function as defined below:
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic trans…