NCT00376675已完成3 期
Long Acting Methylphenidate (Concerta™) for Cancer-Related Fatigue: A Phase III, Randomized, Double-Blind Placebo Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 235
- 主要终点
- Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4
研究概览
简要总结
RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer.
PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer.
详细描述
OBJECTIVES:
Primary
- Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory.
Secondary
- Evaluate the tolerability and adverse events associated with this drug in these patients.
- Study the effect of this drug on quality of life (QOL)-related variables (vitality, sleep quality, overall QOL, QOL domains, other fatigue measures, and perceived treatment efficacy) in these patients.
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)
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
- •Men or women with a history of cancer-related fatigue as defined by a score ≥ 4 on a fatigue numerical analogue scale (0 - 10)
- •Fatigue for ≥ 1 month prior to registration
- •ECOG Performance Score (PS) 0, 1, or 2
- •Life expectancy ≥ 6 months
- •Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma
- •Laboratory values obtained ≤ 30 days prior to registration:
- •Hgb ≥ 10 g/dL
- •Willing and able to provide informed consent
- •Negative pregnancy test (urine or serum) done ≤ 7 days prior to registration, for women of childbearing potential only
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Biological therapy (i.e. immunotherapy, biotherapy), chemotherapy or radiation therapy will be allowed
- •Use of a stable dose of anti-depressants (except tricyclic anti-depressants) will be allowed
- •Erythropoietic agents to treat anemia, and steroids as a part of cancer treatment and for symptom management (except for fatigue) will be allowed
排除标准
- •Hypersensitivity to methylphenidate
- •Any prior use of methylphenidate
- •Concomitant (≤ 2 weeks) use of prescription stimulants (pemoline, modafinil, amphetamines); other medications, herbal products or dietary supplements for fatigue
- •Uncontrolled hypertension [defined as systolic blood pressure (BP) ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg on 2 separate visits ≤ 2 months prior to randomization]; or a resting heart rate > 100
- •Moderate or severe pain as defined by an average daily score ≥ 4 on a pain analog scale (0 - 10)
- •Known brain metastasis or primary CNS malignancy
- •Clinically significant acute or chronic progressive or unstable neurologic (dementia, delirium, or seizure disorder), hepatic, renal, cardiovascular, thyroid, or respiratory disease that would limit participation in the study per MD discretion or judgment
- •Psychiatric disorder such as manic depression, anxiety disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia
- •Major surgery < 4 weeks prior to registration. (Note: Insertion of central venous catheter is not considered major surgery.)
- •Using a drug contraindicated when taken concurrently with methylphenidate: coumarin anticoagulants, anticonvulsants, tricyclic antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline, and pseudoephedrine
- •Note: use of Compazine prescribed as an antiemetic is permitted for use while participating in this study.
- •Additional medical conditions where use of methylphenidate is contraindicated:
- •glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, history of drug or alcohol abuse or intestinal obstruction.
- •Pregnant women or nursing women. Women of childbearing potential who are unwilling to employ adequate contraception. This study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown.
- •Untreated hypothyroidism (TSH ≥ 5)
研究组 & 干预措施
Arm II
Placebo Comparator
Patients receive oral placebo daily on days 1-28.
干预措施: placebo (Other)
Arm I
Experimental
Patients receive oral methylphenidate hydrochloride daily on days 1-28.
干预措施: methylphenidate hydrochloride (Drug)
结局指标
主要结局
Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4
时间窗: Baseline to week 4
The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following: 1. For those completed 4 weeks item: AUC/4; 2. For those completed up to week 3 item: (AUC \* 4) / 3; 3. For those completed up to week 2 item: AUC \* 2; 4. For those completed up to week 1 item: AUC \* 4; The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis.
次要结局
- AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4(Baseline to Week 4)
- Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4(Baseline and Week 4)
- AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4(Baseline to Week 4)
- AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4(Baseline to Week 4)
- Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue(Baseline and Week 4)
- AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4(Baseline to Week 4)
- Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue(Baseline and Week 4)
- Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue(Baseline and Week 4)
研究者
研究点 (235)
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