Étude Pilote de Phase II Sur l'Effet du méthylphénidate Sur la Fonction Cognitive Des Patientes en rémission d'un Cancer du Sein
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in cognitive impairment level
研究概览
简要总结
Cancer-related cognitive Impairment (CRCI), commonly referred to as "chemo brain" or "brain fog"-impact severely on the Quality of Life (QoL) of cancer survivors. However, it still remains underdiagnosed and challenging to treat. One of the treatment options is the use of psychostimulants such as Methylphenidate (MP), but well-designed clinical trials to test its efficacy are limited. We will conduct a phase II study with a mixed method design to explore the preliminary efficacy of MP to improve cognitive function and QoL in breast cancer patients after treatment with chemotherapy and/or radiotherapy and determine the parameters needed for designing a phase III study.
详细描述
Objectives: The main objective of this study is to determine the parameters for a phase III study to measure the efficacy of MP in improving CRCI in women with breast cancer who received chemotherapy and/or radiotherapy. In addition, the profile of drug side effects will be estimated. A better understanding of CRCI and its impact on the activities and QoL of the study population is targeted.
Population: The sample will consist of 40 women in remission of non-metastatic breast cancer whose profile meets the following criteria:
- receiving follow-up at the radio-oncology department of the CHU de Québec-Université Laval or at any other health institutions in Quebec participating in the project;
- complaining about cognitive impairment;
- not having any contraindications to the taking of MP or any medical condition that may interfere with his taking and/or any medical condition that could explain the cognitive impairment.
Before study inclusion, the eligibility of these women will be validated by questionnaires and medical records.
Study design: This study will follow the design of a randomized, double-blind, placebo-controlled trial that includes a mixed methodology (convergent design).
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer stage I, II or III
- •Completed chemotherapy and/or radiotherapy at least 6 months before entering the study
- •Being in remission of breast cancer
- •Complaining of cognitive impairment
排除标准
- •Current or recent use (<2 years) of psychostimulant drugs
- •Women receiving drugs with a potential of interaction with methylphenidate:
- •i. Anticoagulants; ii. Antidepressants with the exception of: amitriptyline (≤75mg); citalopram (≤40mg); desipramine (≤75mg); duloxetine (≤60mg); escitalopram (≤20mg); fluoxetine (≤60mg); fluvoxamine (≤150mg); mirtazapine (≤60mg); nortriptyline (≤50mg); trazadone (≤50mg); venlafaxine (≤150mg); vortioxetine (≤20mg); iii. Drugs (cocaine); iv. Erythropoietin; v. Drugs acting on the cerebral dopaminergic system, including drugs that inhibit monoamine oxidase; vi. John's wort, natural medicines for depression or supplements for fatigue.
- •Conditions that may increase the risk of cognitive impairment or toxicity of methylphenidate such as:
- •i. Pregnancy and breastfeeding ii. Bipolar status iii. Cerebral tumor or any brain injury iv. Metastatic cancer v. Alcohol addiction vi. Active Major depression vii. Parkinson disease viii. Dementia ix. Epilepsia x. Glaucoma xi. Cardiovascular diseases xii. Auto-immunes and chronic inflammatory disease xiii. Cerebrovascular disease xiv. Narcolepsy xv. Pheochromocytoma xvi. Thyrotoxicosis xvii. Motor tic, Tourette syndrome xviii. Generalized anxiety disorder or panic attacks xix. Living under the same roof as people taking Biphentin® 10 mg capsules (this exclusion criteria is necessary because the placebo capsule is identical to the commercial formulation of Biphentin®) xx. Any other medical criteria, according to the clinical judgment of the principal investigator.
研究组 & 干预措施
Methylphenidate HCl 10Mg SR
Participants of the intervention group (n=20) will receive 1 capsule of Methylphenidate HCl 10 mg SR each morning during 14 days during phase 1 and 2 capsules of Methylphenidate HCl 10 mg SR each morning during 14 days during phase 2.
干预措施: Methylphenidate HCl 10Mg SR (Drug)
Placebo Group
Participants of the control group (n=20) will receive 1 capsule of placebo each morning during 14 days during phase 1 and 2 capsules of placebo each morning during 14 days during phase 2.
干预措施: Placebo Group (Drug)
结局指标
主要结局
Change in cognitive impairment level
时间窗: Up to 24 months
'Perceived Cognitive Impairments' (PCI) subscale of the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire (FACT-Cog) test
次要结局
- Methylphenidate side effects(Up to 24 months)
- Methylphenidate effect on fatigue(Up to 24 months)
- Experience of women with cancer-related cognitive impairment in cancer(Up to 24 months)
研究者
Dr Bruno Gagnon
Associate Professor
CHU de Quebec-Universite Laval