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

NCT01501396 | Withdrawn Phase 2

• 1 other identifier: 201202023
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anorexia

Outcome Measures

Primary Outcomes (1)

• Response rates for weight gain

  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 Outcomes (6)

• Safety and tolerability of MA alone and MA + MRZ

  Baseline to 12 weeks (30 days after end of study)

• Weight change (in lbs)

  Baseline to 8 weeks

• Appetite stimulation

  Baseline to 8 weeks

• Quality of life

  Baseline to 8 weeks

• Mood assessments

  Baseline to 8 weeks

Study Arms (2)

Arm A (megestrol alone)

EXPERIMENTAL

Megestrol acetate 800 mg PO daily x 8 weeks

Drug: Megestrol Acetate

Arm B (megestrol plus mirtazapine)

EXPERIMENTAL

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; Drug: Mirtazapine

Interventions

Megestrol Acetate DRUG

Also known as: BDH 1298, Maygace, Megace, Megestil, Niagestin, Pallace

Arm A (megestrol alone); Arm B (megestrol plus mirtazapine)

Mirtazapine DRUG

Also known as: Remeron

Arm B (megestrol plus mirtazapine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Publications (1)

• Vita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4.

  PMID: 36999619 DERIVED

Related Links

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

MeSH Terms

Conditions

Anorexia

Interventions

Megestrol Acetate; Mirtazapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Saiama Waqar, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 29, 2011
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 3, 2014

Record last verified: 2014-01