MDACC Study Summary 2005-0916

Study Summary
No. 2005-0916:.......Advanced Cancers......Shalini Dalal......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2005-0916

Study Title:	Preliminary study to explore the effects of Mirtazapine on appetite in advanced cancer patients

Physician

New Patient Referral



Name:	Shalini Dalal	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6085 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	2

Treatment Agents:	Mirtazapine	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out if Remeron® (mirtazapine) can help to improve appetite in patients with advanced cancer. Researchers also want to learn if mirtazapine can help to improve quality of life for these patients by decreasing common symptoms of advanced cancer (such as insomnia [difficulty sleeping], nausea, pain, and mood change).

Study Objectives / Outcomes

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).

Study Status Information



Study Activation / Registration Date:	01/08/2007

IRB Review and Approval Date:	09/20/2006

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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.

2) Patients > 18 years of age

3) Karnofsky Performance score of > 40 at time of inclusion into study

4) Ability to provide informed consent and comply with study procedures

5) 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).

6) Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment.

7) For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist

8) Patients who are on stable doses of antidepressants for at least 2 months.

9) Patients using corticosteroids, dronabinol, testosterone and progesterone derivatives such as megestrol acetate may be included if they have been on a stable dose for at least 2 weeks.

Exclusion Criteria:

1) Patients who have known dementia or delirium at time of enrollment as determined by a physician.

2) Known hypersensitivity to any ingredient of Mirtazapine

3) Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting

4) Ongoing use of tube feeding or parenteral nutrition

5) Pregnancy or lactation or unwillingness to use contraceptives

6) 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.

Links

Registration Number: NCT00488072
Study Information on Clinical Trials Registry (clinicaltrials.gov)