A Phase 3 interventional study of Olanzapine 5 MG and Placebo in Anorexia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Cairo University · Phase 3, Interventional, and Supportive care
164 patients will be recruited..Adult patients diagnosed with incurable solid tumors and CCAA who presented to Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK) - Kasr Al-Ainy School of Medicine - Cairo University will be randomly distributed into 1:1..82 will receive Olanzapine 5 mg daily at night and 82 patients will receive placebo for 4 weeks. Primary outcome is Change in loss of appetite score from day 0 to day 7 of treatment and secondary outcomes change in body weight, change in loss of appetite score..and change in quality of life
This is a placebo-controlled double-blinded phase III randomized clinical trial. One hundred and sixty-four adult incurable cancer patients under treatment at Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK) - Kasr Al-Ainy School of Medicine - Cairo University during the period from December 2021 to September 2022.
A written informed consent is to be obtained from all patients before entering the study. Then the investigators will give them dietary advice at baseline. Routine labs as complete blood count, liver,kidney function tests and CRP will be obtained to assess safety to start the drug and to assess its dose adjustment.
Participants will be 1:1 randomized to the intervention (olanzapine) arm or the control (placebo) arm. Olanzapine will be given as oral 5 mg tablets (Zyprexa) and the placebo will be given in the form of tablets containing 300 mg of microcrystalline cellulose.
The investigators will prepare 82 jars containing the oral olanzapine tablets and similar 82 jars containing the placebo tablets. Each jar will have a unique number from 1 to 164. The jars will be prepared by Dr.Noha Abdel Razek, the Oncology Pharmacy Direstor at the department.
The codes of the jars will be safeguarded till the end of the study at a closed cupboard at our clinic. The jars will be uncoded only at the end of the study by only one investigator.
The investigators will assess patients' mentality to exclude delirium using Mini Mental Scale (MMS) (Symptom Guidelines of Hospice Palliative Care Program, 2019).
Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
9. Study outcomes:
Primary outcome
o Change in loss of appetite score from day 0 to day 7 of treatment with olanzapine 5 mg orally once daily at night: on the loss of appetite item of the ESAS-r.
Secondary outcomes
Adverse events: assessed weekly using the CTCAE version 5.
10. Sample size: A sample size of 164 patients will be recruited to our study. Considering a 1.5-point change on the 0-10 loss-of-appetite scale of the ESAS to be of clinical importance (Del Fabbro et al, 2013) and a standard deviation of 2.9 (Blum et al, 2014), 63 evaluable patients are needed in each arm to detect a 1.5 points difference in the average change of anorexia score between the two arms with a two-sided 0.05 significance and 80% power. To compensate for 30% dropout rate and taking into consideration the non-parametric analysis of the primary endpoint, the plan is to recruit a total of 164 patients. Sample size calculation was done using G*Power Version 3.1.9.6. (Faul et al, 2009).
11. 11- Statistical analysis plan Categorical variables will be expressed as number and percentage. A Chi-square test was used to determine the significance of difference in categorical variables between two or more groups.
The normality of continuous variables will be tested using Shapiro-Wilk test. Normally-distributed continuous variables will be expressed as mean and standard deviation, and abnormally-distributed as median and interquartile range. The significance of difference in normally distributed continuous variables between two groups will be tested using independent sample t-test; and for abnormally-distributed variables, Mann-Whitney U test will be used. Paired-samples t-test was used to test the difference in normally-distributed continuous variables at time intervals; and the Wilcoxon signed rank test for abnormally-distributed. All statistical tests will be two-sided and a p-value value \<0.05 will be considered significant.
Per-protocol analysis of the 1ry outcome and other outcome measures at day 14 will include all patients who completed 14 days of treatment according to the protocol. Similarly, patients who completed 28 days of treatment according to the protocol will be included in per-protocol analysis at 28 days.
An intention-to-treat analysis of the 1ry outcome and other outcome measures at day 14 will be performed after imputation of missing values. Participants who withdrew from the study after randomization and before receiving a single dose of the intervention were excluded from the intention-to-treat analysis. Missing outcome values will be imputed using the k nearest neighbour (kNN) imputation method with a k value of 11. This will be done using the Visualization and Imputation of Missing Values (VIM) package (Templ et al, 201) of R software, version 4.0.5 (R Core Team 2021).
Statistical analysis was executed using MedCalc version 19.5.3 for Windows (MedCalc Software Ltd, Ostend, Belgium).
415 studies on the registry are indexed under Anorexia; 68 are open to participants now.
This study's enrollment of 164 is above the median of 42 across 290 interventional studies indexed under Anorexia.
Browse Anorexia studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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o Age ≥ 18 years old at time of informed consent
Exclusion Criteria:
o Weight gain for known cause, e.g. oedema or ascites.
82 patients will receive olanzapine 5 mg daily at night for 4 weeks
Drug: Olanzapine 5 MG
82 patients will receive placebo for 4 weeks
Drug: Placebo
, Olanzapine (OLZ) is an atypical antipsychotic agent that blocks multiple neurotransmitters: dopamine at D1, D2, D3 and D4 brain receptors, serotonin at 5-HT2a , 5-HT2c, 5-HT3, and 5-HT6receptors, catecholamines at alpha 1 adrenergic receptors, acetylcholine at muscarinic receptors, and histamine at H1 receptors is suggested to have a valuable role in CAC
Also known as: Zyprexa
Tablets containing 300 mg of microcrystalline cellulose. It will be identical to the active drug
appetite score
Change in loss of appetite score from day 0 to day 7 of treatment with olanzapine 5 mg orally once daily at night: on the loss of appetite item of the ESAS-r. Where 0 is no loss of appetite and 10 worst appetite ever.
Time frame: 1 week
appetite score
o Change in loss of appetite score from day 0 to days 14, 21 and 28: on the loss of appetite item of the ESAS-r. Wher 0 is no loss of appetite and 10 worst appetite ever.
Time frame: weekly till week 4
Change in quality-of-life
o Change in quality-of-life from day 0 to day 28: assessed using the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) quality-of-life questionnaire.
Time frame: day 28
body weight
Change in body weight from day 0 to day 28: using BF100 (Beurer Company).
Time frame: day 28
body mass index
Change in body mass index from day 0 to day 28.
Time frame: day 28
handgrip strength
o Change in handgrip strength from day 0 to day 28: using JAMAR Digital Hand Dynamometer (Patterson Medical Company)(model 12-0604).
Time frame: day 28
lean body mass
o Change in lean body mass from day 0 to day 28: by bioimpedence analysis using BF100 (Beurer Company).
Time frame: day 28
Fatigue
Change in fatigue from day 0 to day 28: using the fatigue item of the ESAS-r. Wher 0 is no fatigue and 10 is worst fatigue ever.
Time frame: day 28
CRP
Change in CRP level from day 0 to day 28.
Time frame: day 28
Adverse events
Adverse events: assessed weekly using the CTCAE version 5.
Time frame: weekly till day 28
Plan to share: No
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Ran from Dec 2021 to primary completion in Nov 2022, 10 months.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Olanzapine