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Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia (MCACS100)

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ClinicalTrials.gov Identifier: NCT03254173
Recruitment Status : Not yet recruiting
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Catherine Naseef Hunter, Kasr El Aini Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Advanced Cancer Cancer Associated Anorexia - Cachexia Drug: Mirtazapine 30 mg oral tablets Drug: Placebo oral tablets Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded randomized controlled trial.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
  • Treatment allocation will be concealed from patients, investigators, and study coordinators enrolling the participants.
  • The pills used in the study ( either remeron or placebo ) will be kept into opaque containers , in order to be concealed from patients , investigators and study coordinators.
Primary Purpose: Treatment
Official Title: Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia : a Randomized Controlled Clinical Trial
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Mirtazapine

Arm Intervention/treatment
Active Comparator: Arm A
Mirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets ) , as half tablet daily , i.e , 15mg daily , before sleep for a duration of 8 weeks
Drug: Mirtazapine 30 mg oral tablets
Mirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets) , half tablet before sleep for 8 weeks
Other Name: Remeron 30 mg oral tablets

Placebo Comparator: Arm B
Placebo oral tablets , as half tablet daily before sleep for a duration of 8 weeks
Drug: Placebo oral tablets
Placebo oral tablets , half tablet daily before sleep for 8 weeks




Primary Outcome Measures :
  1. Efficacy of mirtazapine in appetite stimulation in patients with cachexia due to advanced cancer with a change of increase of 1.5 degree on a numerical scale of 0 -10 as a target . [ Time Frame: It will be assessed at week 4 of receiving the intervention. The 4-week duration of treatment is of sufficient length to obtain benefit from an effective intervention for appetite. ]
    Efficacy of mirtazapine in appetite stimulation in patients with cachexia due to advanced cancer with a change of increase 1.5 degree on a scale of 0-10 as a target , where 0 represents minimum appetite and 10 represents maximum appetite.


Secondary Outcome Measures :
  1. Efficacy of mirtazapine in weight gain. ''Improved'' weight will be defined as a gain of ≥ 1 kg and ''maintained weight'' will be defined as a loss of <500 g, or a gain of <1 kg. [ Time Frame: It will be assessed at week 8 of receiving the intervention. ]
    Efficacy of mirtazapine in weight gain in patients with cachexia due to advanced cancer.''Improved'' weight will be defined as a gain of ≥ 1 kg and ''maintained'' will be defined as a loss of <500 g, or a gain of <1 kg.

  2. Effect of mirtazapine in improving other symptoms , such as : nausea , vomiting , sleep with a change of decrease of ≥ 2 points on the ESAS ( Edmonton Symptom Assessment Scale ) from baseline. [ Time Frame: It will be assessed at week 8 of receiving the intervention. ]
    Effect of mirtazapine in improving other symptoms , such as : nausea , vomiting , sleep in patients with cachexia due to advanced cancer with a change of decrease of ≥ 2 points on the ESAS scale from baseline. The ESAS is both valid and reliable in the assessment of the intensity of symptoms in patients with cancer.

  3. Effect of mirtazapine in improving quality of life : will be measured by an increase of 16 points in the FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale . [ Time Frame: It will be assessed at week 8 of receiving the intervention. ]

    Effect of mirtazapine in improving quality of life in patients with cachexia due to advanced cancer. This will be measured by an increase of 16 points in the FAACT which indicates ''improved'' quality of life. The FAACT questionnaire ( Functional Assessment of Anorexia\Cachexia Therapy ) with anorexia \ cachexia subscale 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.


  4. Changes in inflammatory cytokines associated with mirtazapine administration : quantitative c-reactive protein (CRP) , IL-6, and YKL-40 serum levels . [ Time Frame: It will be assessed at week 8 of receiving the intervention. ]
    Changes in inflammatory cytokines associated with mirtazapine administration in patients with cachexia due to advanced cancer : quantitative c-reactive protein (CRP) and comparative analysis by enzyme-linked immunoassay (ELISA) will be performed on IL-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.

  5. Safety of mirtazapine use : Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 [ Time Frame: It will be assessed at baseline , then at 14-day intervals until day 28 and after 30 days from the date of the last dose of the study drug. ]

    Safety of mirtazapine use in patients with cachexia due to advanced cancer.Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed advanced cancer.
  • Patients with appetite score equal or more than 4 on a 0 to 10 scale (10 _ worst appetite).
  • Patients with weight loss more than 5 % of body weight over 6 months . Or : Patients with any degree of weight loss more than 2 % associated with BMI ( body mass index ) of less than 20.
  • Patients able to take pills orally and not dependent on tube feeding (no oral mucosal inflammation interfering with oral intake or dysphagia as determined by clinical examination).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Normal organ function (creatinine ≤2× upper limit of normal, bilirubin ≤2; upper limit of normal).
  • Ability to understand and willingness to sign written informed consent.
  • Patients could be receiving concurrent chemotherapy or radiation therapy.
  • Patients with an expected life span of at least 3 months.

Exclusion Criteria:

  • Patients with weight gain for known cause , e.g. , ascites.
  • Premenopausal women with childbearing potential with a positive pregnancy test.
  • Patients unable to maintain oral intake .
  • Patients with dementia or delirium.
  • Patients with uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression will be excluded until their symptoms had stabilized for at least 2 weeks.
  • Because improvement in anorexia and/or weight in depressed individuals could be due to an antidepressant effect of mirtazapine, rather than to a direct effect on anorexia, patients with moderate to severe depressive symptoms will be also excluded. the screening instrument will be a single-item interview assessing depressed mood of the Schedule for Affective Disorders and Schizophrenia (SADS) instrument which is validated and highly accurate in screening for depression when compared to the gold standard of semistructured diagnostic interviews, and is rated on a 6-point Likert scale, where 0 = no depression and 6 = extreme feelings of depression. Patients with a score of 4 or more will be excluded from the study as they are considered to be at high risk for depression.
  • No treatment with antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days prior to or during protocol therapy.
  • Patients with untreated vitamin B12 deficiency or endocrine abnormalities that could affect appetite, such as thyroid dysfunction and hypoadrenalism.
  • Patients on supplements or medications with potential appetite-stimulating activity, such as megestrol acetate, corticosteroids, or thalidomide, will be excluded unless they are put on a stable dose for more than 2 weeks and continue to experience poor appetite.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254173


Contacts
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Contact: Catherine N Hunter, Ass. lecturer +201287304063 catherinenaseef123@gmail.com
Contact: Samy A Sirafy, Prof. +201118035647 alsirafy@kasralainy.edu.eg

Sponsors and Collaborators
Catherine Naseef Hunter
Investigators
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Principal Investigator: Catherine N Hunter, Ass. lecturer Clinical Oncology Department at Kasr Al Ainy NEMROCK

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Responsible Party: Catherine Naseef Hunter, Assisstant Lecturer at clinical oncology department at Kasr Al Ainy NEMROCK, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03254173     History of Changes
Other Study ID Numbers: MCACS100
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be kept in records at clinical oncology department at Kasr Al Ainy NEMROCK to be available at anytime and shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Catherine Naseef Hunter, Kasr El Aini Hospital:
Mirtazapine
Anorexia - Cachexia
Advanced Cancer
Appetite

Additional relevant MeSH terms:
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Wasting Syndrome
Anorexia
Cachexia
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Mirtazapine
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents