Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia — MCACS100  

Advanced Cancer Clinical Trial

Official title: Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia : a Randomized Controlled Clinical Trial

Status Completed

Clinical Trial Summary

A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome.

Two arms will be compared . Arm A will involve 50 patients with confirmed advanced cancer receiving mirtazapine 15 mg once daily for 8 weeks & Arm B will involve another 50 patients with confirmed advanced cancer receiving placebo for 8 weeks.

Both arms will be compared to assess efficacy of mirtazapine in appetite stimulation primarily and to assess other outcomes secondarily which will be discussed later in details.

Clinical Trial Description

• A Written consent is to be obtained from all patients before being enrolled in the study.

• Baseline Complete Blood Count , Liver function tests and kidney function tests will be obtained to assess safety to start the drug and to assess its dose adjustment.

• Two arms will be compared : mirtazapine oral 15mg daily versus placebo. This will be conducted on a double-blinded basis.

• Oral mirtazapine ( REMERON , RD , 30 mg tablets , Organon ) will be the original FDA approved drugs that will be used in the study.

• Treatment allocation will be concealed from patients, investigators, and study coordinators enrolling the participants.

• All patients will be counseled and given dietary advice by a dietician at baseline.

• Patients will be permitted to continue treatment at the same dose as scheduled as long as weight was stabilized (no loss greater than 10 % of body weight at baseline).

• Duration of therapy : Patients will remain on protocol for a duration of 8 weeks as long as they did not develop serious concurrent illness preventing further treatment, unacceptable adverse events (grade 3 or higher), the patient decides to withdraw from study, or the investigator judges that it is in the patient's best interest to discontinue treatment due to general or specific health conditions.

• Demographic data will include performance status, tumor type, sex, age, and percentage weight loss.

• The ESAS scale (Edmonton Symptom Assessment Scale ) will be used to assess the following 10 symptoms experienced by patients with cancer during the previous 24 hours:

1. pain.

2. Fatigue.

3. Nausea.

4. Depression.

5. Anxiety.

6. Drowsiness.

7. Dyspnea.

8. Anorexia.

9. Sleep disturbance.

10. And feelings of well-being.

The severity of each symptom is rated on a numerical scale of 0 to 10 (0_no symptom, 10_worst possible severity). The ESAS is both valid and reliable in the assessment of the intensity of symptoms in patients with cancer.

• The FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale will be used to assess quality of life among the studied patients , in a form of questionnaire including :

1. Physical well-being.

2. Social well-being.

3. Emotional well-being.

4. Functional well-being.

5. Additional concerns.

The patient rates the answer on a scale of 0 to 4. The FACIT - Pal scale is internally consistent , reliable and valid as a measure of health-related quality of life for persons with advanced cancer.

We will contact their website to get the licence to use the questionnaire and to get its translated version.

• Anthropometric measures to assess efficacy of mirtazapine in weight gain :

1. Assessment of weight of the patient .

2. Assessment of muscle strength ( via hand grip dynamometry , using the device named Lite 200 lb , Fabrication Enterprises Incorporated Company).

3. Assessment of lean ( via bioimpedance analysis , using the device named BF100 , Beurer Company ).

• Biological methods to assess efficacy of mirtazapine in modulating inflammatory cytokine media : quantitative c-reactive protein (CRP) and comparative analysis by enzyme-linked immunoassay (ELISA) will be performed on IL-6 ( Interleukin - 6 ) , and YKL-40 serum levels according to availability. They will be obtained at baseline (day 1 of treatment, immediately before first dose) and at week 8.

• Evaluation of safety and tolerability Patients who will receive at least one dose of study medication will be done.

• A traditional definition of dose-limiting toxicity (DLT) within the first cycle Will be used (any grade 3 non-hematologic or grade 4 hematologic toxicity within 4 weeks and assessed as being at least possibly related to study drug).

• A toxicity questionnaire will be done at baseline and then at 14-day intervals until day 28.

To fully assess the toxicity profile of the drug, the safety evaluation period in the trial will be extended 30 days from the date of the last dose of study drug. ;

Related Conditions & MeSH terms

• Advanced Cancer
• Anorexia
• Cachexia
• Cancer Associated Anorexia - Cachexia

• NCT number: NCT03254173
• Study type: Interventional
• Source: Kasr El Aini Hospital
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 26, 2018
• Completion date: October 17, 2019