- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501396
Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite
January 31, 2014 updated by: Washington University School of Medicine
Treatment of Cancer Anorexia-cachexia Syndrome (CACS) With Mirtazapine and Megestrol Acetate
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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 phenylalanine)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (megestrol alone)
Megestrol acetate 800 mg PO daily x 8 weeks
|
Other Names:
|
Experimental: Arm B (megestrol plus mirtazapine)
Megestrol acetate 800 mg PO daily x 8 weeks Mirtazapine 15 mg PO at bedtime x 1 week followed by 30 mg PO at bedtime x 7 weeks |
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rates for weight gain
Time Frame: Baseline to 8 weeks
|
Determine the rates of >= 5% weight gain in the treatment groups.
Compare the difference of the response rate between the 2 groups.
|
Baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of MA alone and MA + MRZ
Time Frame: Baseline to 12 weeks (30 days after end of study)
|
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
|
Baseline to 12 weeks (30 days after end of study)
|
Weight change (in lbs)
Time Frame: Baseline to 8 weeks
|
Change over time as well as the difference between groups for weight (in lbs) will be analyzed.
|
Baseline to 8 weeks
|
Appetite stimulation
Time Frame: Baseline to 8 weeks
|
Assessed using Simplified Nutritional Appetite Questionnaire (SNAQ).
The change over time as well as the difference between groups will be analyzed.
|
Baseline to 8 weeks
|
Quality of life
Time Frame: Baseline to 8 weeks
|
Assessed using the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).
The Change over time as well as the difference between groups will be analyzed.
|
Baseline to 8 weeks
|
Mood assessments
Time Frame: Baseline to 8 weeks
|
Measured using CES-D.
The Change over time as well as the difference between groups will be analyzed.
|
Baseline to 8 weeks
|
Evaluation of biochemical markers
Time Frame: Baseline to 8 weeks
|
Explore the relationship between weight gain and serum markers of nutritional status (prealbumin, transferrin, C-reactive protein, TNF-alpha, and IL-1 and IL-6).
|
Baseline to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
December 20, 2011
First Submitted That Met QC Criteria
December 28, 2011
First Posted (Estimate)
December 29, 2011
Study Record Updates
Last Update Posted (Estimate)
February 3, 2014
Last Update Submitted That Met QC Criteria
January 31, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Anorexia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Appetite Stimulants
- Mirtazapine
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- 201202023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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