Olanzapine in Cancer Cachexia-Associated Anorexia: a Double-Blind Placebo-Controlled Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- appetite score
研究概览
简要总结
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
详细描述
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.
• Method of randomization: The randomization sequence will be generated online by "Random.org".The investigators will use the sequence generator for numbers, where the minimum value is "1" and the maximum value is "164".
• Method of blinding:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
We 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 Director 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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Age ≥ 18 years old at time of informed consent
- •Confirmed diagnosis of incurable solid tumor (cancer patients with incurable disease receiving anti-cancer therapy with palliative intent or best supportive care).
- •Loss of appetite score ≥ 4 on a 0 to 10 loss of appetite scale where 10 = worst possible lack of appetite as assessed by the Arabic version of Edmonton Symptom Assessment Scale (R/ESAS r) (ESAS-r, 2021).
- •Cachexia defined as "loss > 5% of body weight over the last 6 months" or "any degree of weight loss > 2 % associated with a body mass index (BMI) < 20" (Fearon et al, 2011).
- •Ability to take pills orally and not dependent on tube feeding (no oral mucosal inflammation, active dysphagia or gastrointestinal tract obstruction).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Ability to understand and communicate in Arabic and willingness to sign a written informed consent.
- •Patients were allowed to receive three-weekly regimens of anti-cancer treatment with palliative intent except those containing highly emetogenic chemotherapeutic (HEC) agents/regimens according to the American Society of Clinical Oncology (Hesketh et al, 2020).
- •Clinically-predicted survival of > 3 months.
- •Normal organ function (creatinine ≤2× upper limit of normal, bilirubin ≤2; upper limit of normal).
排除标准
- •o Weight gain for known cause, e.g. oedema or ascites.
- •Treatment with other antipsychotic agents during the past 30 days.
- •Hypersensitivity to olanzapine.
- •Premenopausal women with childbearing potential with a positive serum B-HCG pregnancy test.
- •Inability to maintain oral intake.
- •Central nervous system disease (e.g., brain metastases, seizure disorder, schizophrenia, bipolar disorder, dementia or delirium).
- •Patients on supplements or medications with potential appetite-stimulating activity, such as megestrol acetate, corticosteroids, or thalidomide.
- •Patients unwilling or unable to comply with the protocol.
- •Nausea and/or vomiting score >3 on a 0 to 10 scale where 10 = extreme nausea/vomiting.
研究组 & 干预措施
Olanzapine
82 patients will receive olanzapine 5 mg daily at night for 4 weeks
干预措施: Olanzapine 5 MG (Drug)
Placebo
82 patients will receive placebo for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
appetite score
时间窗: 1 week
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.
次要结局
- body weight(day 28)
- appetite score(weekly till week 4)
- body mass index(day 28)
- lean body mass(day 28)
- CRP(day 28)
- Change in quality-of-life(day 28)
- handgrip strength(day 28)
- Adverse events(weekly till day 28)
- Fatigue(day 28)
研究者
Nada Osama Ahmed
Demonstrator (Dr)
Cairo University