Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Completion of intervention
研究概览
简要总结
Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most commonly reported disabling symptoms experienced by patients with advanced cancer. However, there are currently limited evidence-based pharmacologic interventions available. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the effect of modafinil in managing CRF and CRCI, and to test the feasibility of carrying out the study.
详细描述
Background:
Patients with advanced cancer often experience various disabling symptoms. Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most common reported symptoms, yet the availability of evidence-based pharmacologic interventions is limited.
CRF can be defined as a "distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning." CRF is experienced by over 75% of patients with advanced cancer.
CRCI is defined as a decline in one or more areas of cognitive function, including attention and concentration, executive functioning, information processing speed, language, visuospatial skill, psychomotor ability, and memory. It is estimated that up to 40% of patients experience CRCI prior to any treatment; up to 75% during their treatment; and up to 60% upon completion of therapies.
Modafinil is a psychostimulant that has been studied in the context of CRF and daytime sleepiness. Its mechanism of action is not clear, but it is thought to promote wakefulness through dopaminergic neurotransmission which has been hypothesized to play a role in CRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •18 years of age or older with stage III or IV cancer diagnosis
- •Estimated prognosis ≥ 3 months
- •Eastern Cooperative Oncology Group (ECOG) Score 0-2
- •Experiencing cancer-related fatigue, defined as a score of 4 or greater on the Fatigue item of the Edmonton Symptom Assessment System-revised-constipation/sleep (ESAS-r-cs)
- •Ability to understand and communicate in English
- •Ability to give first-person informed consent
排除标准
- •Currently receiving or have received cytotoxic chemotherapy in the last 6 weeks
- •Allergy to modafinil or placebo contents
- •Dose change of prednisone or dexamethasone in the past 7 days or planned dose change during study period
- •Blood transfusion in the last 2 weeks
- •Hemoglobin lower than 80 g/L measured in the last 4 weeks
- •TSH above normal range in the last 4 weeks
- •Severe liver dysfunction (total bilirubin >3x upper limit of normal, or aspartate aminotransferase or alanine aminotransferase >5x upper limit of normal)
- •Known brain metastasis or primary brain tumor
- •Documented dementia diagnosis
- •Documented major psychiatric illness including major depressive episode, bipolar disorder, schizophrenia
- •Uncontrolled hypertension as defined by a blood pressure greater than 140/90mmHg
- •Unstable angina
- •Recent (<6 months previous) myocardial infarction
- •Evidence of left ventricular hypertrophy or ischemia on ECG
- •Arrythmia (e.g., atrial fibrillation)
- •Coronary artery disease with Canadian Cardiovascular Society Symptoms Class >1
- •Taking high dose selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants
- •Taking any benzodiazepine at any dose
- •Taking any amphetamine at any dose
- •Taking any monoamine oxidase inhibitor (MAOI) at any dose
- •Taking any azole anti-fungal medication (e.g., fluconazole, itraconazole, or ketoconazole)
- •Taking any of the following medications at any dose:
- •Methylphenidate
- •Cyclosporine
- •Propranolol
- •S-mephenytoin
- •Ethinyl estradiol
- •Clomipramine
- •Inability to ingest oral capsule
- •Pregnancy or lactation, or trying to conceive
- •Any other history, condition, therapy, or uncontrolled intercurrent illness which could, in the opinion of the Qualified Medical Investigator, affect compliance with study requirements or which would make the participant unsuitable for this study.
- •Simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to screening visit that could, in the judgment of the Qualified Medical Investigator, affect the patient's participation in or outcome of this clinical trial.
研究组 & 干预措施
Placebo
Two 100mg placebo capsules once daily for 2 weeks
干预措施: Placebo (Other)
Modafinil
Two 100mg modafinil capsules once daily for 2 weeks
干预措施: Modafinil (Drug)
结局指标
主要结局
Completion of intervention
时间窗: 2 years
We will consider the intervention to be feasible if at least 75% of enrolled participants complete the full intervention protocol.
Recruitment rate
时间窗: 2 years
The number of patients approached, total participants screened for eligibility, and reason for ineligibility or refusal to participate will be documented. We will consider the study successful if we can enroll 40 participants over a 2-year study period, with a recruitment rate of 15%.
Completion of follow-up
时间窗: 2 years
We will consider the intervention to be feasible if at least 75% of enrolled participants complete all assessments at 1-week follow-up.
Fatigue
时间窗: 2 weeks
Change in fatigue score evaluated using Multidimensional Fatigue Inventory (MFI).
次要结局
- Patient satisfaction with MFI(2 weeks)
- Adverse events(2 weeks)
- Cognition(2 weeks)
- Quality of Life(2 weeks)