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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01501396
First received: December 20, 2011
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Anorexia
Drug: Megestrol Acetate
Drug: Mirtazapine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Treatment of Cancer Anorexia-cachexia Syndrome (CACS) With Mirtazapine and Megestrol Acetate

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Response rates for weight gain [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Determine the rates of >= 5% weight gain in the treatment groups. Compare the difference of the response rate between the 2 groups.


Secondary Outcome Measures:
  • Safety and tolerability of MA alone and MA + MRZ [ Time Frame: Baseline to 12 weeks (30 days after end of study) ] [ Designated as safety issue: Yes ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

  • Weight change (in lbs) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Change over time as well as the difference between groups for weight (in lbs) will be analyzed.

  • Appetite stimulation [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Assessed using Simplified Nutritional Appetite Questionnaire (SNAQ). The change over time as well as the difference between groups will be analyzed.

  • Quality of life [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Assessed using the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The Change over time as well as the difference between groups will be analyzed.

  • Mood assessments [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Measured using CES-D. The Change over time as well as the difference between groups will be analyzed.

  • Evaluation of biochemical markers [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 0
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (megestrol alone)
Megestrol acetate 800 mg PO daily x 8 weeks
Drug: Megestrol Acetate
Other Names:
  • BDH 1298
  • Maygace
  • Megace
  • Megestil
  • Niagestin
  • Pallace
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

Drug: Megestrol Acetate
Other Names:
  • BDH 1298
  • Maygace
  • Megace
  • Megestil
  • Niagestin
  • Pallace
Drug: Mirtazapine
Other Name: Remeron

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501396

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Saiama Waqar, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01501396     History of Changes
Other Study ID Numbers: 201202023
Study First Received: December 20, 2011
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms
Megestrol
Megestrol Acetate
Mirtazapine
Mianserin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Antagonists
Adrenergic Antagonists

ClinicalTrials.gov processed this record on July 23, 2014