Effects of Mirtazapine on Appetite in Advanced Cancer Patients

NCT00488072 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2005-0916NCI-2011-02822
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days). Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days) Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days) Other Objectives: To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days). To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).

Conditions

Anorexia; Advanced Cancer; Weight Loss; Insomnia

Keywords

Advanced Cancer; Anorexia; Weight Loss; Insomnia; Appetite; Mirtazapine; Placebo

Outcome Measures

Primary Outcomes (1)

• Comparison of ESAS scores in Appetite

  Primary analysis is a comparison of the difference scores in appetite between baseline and 15 days in the two groups. 2-sample t test used to compare differences between groups or a nonparametric test such as the Wilcoxon test if the data are non-normally distributed. A difference of 2 or more in change scores considered to be clinically meaningful.

  Baseline, and on days (+/-3) 15 and 28

Secondary Outcomes (1)

• Insomnia (as measured by Pittsburgh Sleep Quality Index)

  On day 15 ( +/- 3 days), and day 29 ( +/- 3 days)

Study Arms (2)

Mirtazapine

EXPERIMENTAL

Mirtazapine 15 mg by mouth (PO) daily for 15 days; Day 22-29, increased to 30 mg PO daily.

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

One placebo tablet by mouth daily.

Drug: Placebo

Interventions

Mirtazapine DRUG

15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.

Mirtazapine

Placebo DRUG

One placebo tablet by mouth daily.

Placebo

Eligibility Criteria

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

You may qualify if:

• Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of \> 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be \> 4/10 on ESAS.
• Patients \> 18 years of age
• Ability to provide informed consent and comply with study procedures
• Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/- 3 days), 8 (+/- 3 days), 16 ( +/- 3 days), and 22 (+/- 3 days) and return to outpatient clinic for evaluation on days 15 (+/- 3 days), and 29 (+/- 3 days).
• For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist
• Drowsiness of \</= 4/10 on ESAS at baseline due to known potential sedating effects of Mirtazapine
• Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study (with the permission of their Attending MD) if they have been on stable dose for at least 2 weeks.
• Patients who are on stable doses of antidepressants for at least 2 months.

You may not qualify if:

• Patients who have known dementia or delirium at time of enrollment as determined by a physician.
• Known hypersensitivity to any ingredient of Mirtazapine
• Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting
• Ongoing use of tube feeding or parenteral nutrition
• Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment.
• Pregnancy or lactation or unwillingness to use contraceptives
• A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of \> 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation.
• Patients on chronic use of benzodiazepines are excluded

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

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

• MD Anderson Cancer Center

MeSH Terms

Conditions

Anorexia; Weight Loss; Sleep Initiation and Maintenance Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shalini Dalal, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 19, 2007
• Study Start: January 8, 2007
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-12

Locations

US (1)