Is Clarithromycin a Potential Treatment for Cachexia in People With Lung Cancer?
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- Feasibility of a phase 3 study
研究概览
简要总结
This study aims to identify if clarithromycin (CLM) has potential as a widely available and inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive a placebo.
详细描述
Clarithromycin has been reported to significantly improve markers of inflammation, body weight, need for hospital admission and survival in 42 patients with NSCLC. Compared to patients receiving best supportive care only, those receiving Clarithromycin had an improved median survival of ~8 months (535 vs. 277 days), stayed at home longer (439 vs. 139 days) and reported no adverse effects.
In another study, 33 patients with NSCLC were given Clarithromycin for 3 months and compared to a matched control group there was a reduction in IL-6 levels which correlated with an improvement in body weight (gain 4 vs. 1kg) and survival. Thus, by reducing inflammation, Clarithromycin may be impeding the cachectic process, preserving body weight, physical function and independence and increasing survival.
These studies of Clarithromycin in NSCLC have limitations, e.g. lack of placebo-control, no direct assessment of lean body mass.
This feasibility study will obtain data to inform the viability and design of a larger randomised, double-blind, placebo-controlled, phase III study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults with stage IV, pathologically confirmed, NSCLC not suitable for/declining/not tolerating 1st/2nd-line palliative chemotherapy, or following completion of 1st/2nd-line palliative chemotherapy
- •A likely prognosis of ≥3 months.
- •Cachexia on the basis of any of the following, weight loss >5% over past 6 months, or BMI <20kg/m2 and weight loss >2%, or appendicular skeletal muscle index determined by duel energy x-ray absorptiometry consistent with sarcopenia and weight loss >2%.
- •Systemic inflammation on the basis of a C-reactive protein >10mg/L.
- •Adequate renal function as defined by creatinine ≤132micromol/L and eGFR ≥30mL/min/1.73m2
- •Adequate liver function as defined by the following parameters, bilirubin ≤25micromol/L, and AST and ALT ≤2 times upper limit of normal, unless liver metastases, in which case ≤5 times upper limit of normal
- •Prepared to suspend, if necessary, the use of certain statins and/or substitute the use of domperidone for an alternative anti-emetic for the duration of the study
排除标准
- •ECOG Performance Status 3 or 4
- •Little or no food intake
- •Weight loss >10% in 1 month or >20% in total
- •Known hypersensitivity to clarithromycin
- •Inability to accurately measure QT interval, e.g. atrial fibrillation
- •QTc prolongation >450 milliseconds in a male, or 470 milliseconds in a female
- •History of ventricular arrhythmia
- •Severe cardiac insufficiency (NYHA class >2)
- •Untreated hypokalaemia/hypomagnesaemia
- •Active infection requiring antibiotics
- •Current or recent (within last 4 weeks) history of Clostridium difficile, eating disorder, dysphagia, malabsorption or diarrhoea
- •Untreated adrenal or thyroid diseases
- •Brain metastases
- •Use of corticosteroids/progestogens
- •Use of chemotherapy, other immunosuppressive, or antiviral (e.g. hepatitis C, HIV) drugs within 4 weeks
- •Drugs which are contra-indicated (except certain statins which can be temporarily suspended and domperidone which can be substituted for an alternative anti-emetic) or should be avoided in patients receiving clarithromycin, either because of the risk of a drug-drug interaction and/or prolonged QT
- •Pregnancy
- •Breast Feeding
研究组 & 干预措施
Clarithromycin
Clarithromycin 250mg by mouth twice a day for 8 weeks
干预措施: Clarithromycin (Drug)
Placebo
Placebo matched capsule one capsule by mouth twice a day for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility of a phase 3 study
时间窗: 1 year
The number of patients recruited to the study as a measure of feasibility.
次要结局
- Tolerability of clarithromycin(1 year)
- Safety of clarithromycin(1 year)
- Effect of clarithromycin(1 year)