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Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anorexia

Intervention: Megestrol Acetate (Drug); Mirtazapine (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Saiama Waqar, M.D., Principal Investigator, Affiliation: Washington University School of Medicine


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.

Clinical Details

Official title: Treatment of Cancer Anorexia-cachexia Syndrome (CACS) With Mirtazapine and Megestrol Acetate

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Response rates for weight gain

Secondary outcome:

Safety and tolerability of MA alone and MA + MRZ

Weight change (in lbs)

Appetite stimulation

Quality of life

Mood assessments

Evaluation of biochemical markers


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 =<


- 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 transaminase

[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2. 5 x institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60

mL/min/1. 73 m^2 for patients with creatinine levels above institutional normal

- Patient must be able to understand and willing to sign a written informed consent

document Exclusion Criteria:

- Patient must not be receiving any other investigational agents

- Patient must not be receiving any tube feeds or parenteral nutrition

- Patient must not be taking either MA or MRZ within 4 weeks prior to enrolling on the

study, prior use of either MA or MRZ more than 4 weeks before enrollment is allowed

- Patient must not be taking any medication for appetite stimulation within 4 weeks

prior to enrolling on the study; prior use of an appetite stimulant more than 4 weeks before enrollment is allowed

- Patient must not have a known seizure disorder

- Patient must not have received abdominal radiation within 4 weeks of enrolling on the

study; patients who have received abdominal radiation more than 4 weeks prior to enrollment may participate in the study, as long as they have recovered from toxicities of radiation therapy

- Patient must not be taking chronic systemic corticosteroids (e. g., prednisone,

dexamethasone) within the 4 weeks prior to study entry or while on study (unless as pre-medication for chemotherapy)

- Patient must not have moderate to severe depression defined as score of >= 20 on the

Center for Epidemiologic Studies Depression Scale (CES-D)

- Patient must not be taking any anti-depressant therapy within the 4 weeks prior to

study entry

- Patient must not be on antipsychotic therapy such as risperidone, quetiapine,

clozapine, phenothiazine, or butyrophenone for 30 days prior to study; patient may receive prochlorperazine or other phenothiazines as antiemetic therapy

- Patient must not have a history of phenylketonuria (MRZ compounds contain


- Patient must not have active dysphagia or gastrointestinal tract obstruction

- Patient must not have a previous history of deep venous thrombosis, pulmonary

embolism, or thrombophlebitis

- Patient must not be receiving any other agent to increase appetite or weight such as

growth hormone (GH), insulin-like growth factor (IGF-1), growth hormone-releasing hormone, insulin-like growth factor binding protein-3 (IGFBP-3), or cannabinoids within the 6 weeks prior to study entry

- Patient must not have a body mass index (BMI) > 30

- Patient must not have a history of allergic reactions attributed to compounds of

similar chemical or biologic composition to MA or MRZ

- Patient must not have any uncontrolled intercurrent illness including, but not

limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Mirtazapine can cause non-teratogenic adverse effects on the developing human fetus

at the recommended therapeutic dose; for this reason and because MA as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of childbearing potential must have a negative pregnancy test prior to study entry

Locations and Contacts

Additional Information

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Starting date: September 2013
Last updated: January 31, 2014

Page last updated: August 23, 2015

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