A Combination Therapy to Treat Cancer-Related Fatigue - NCI R01
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Level of cancer-related fatigue in all groups
研究概览
简要总结
This phase II/III trial studies how well methylphenidate and exercise work in reducing cancer-related fatigue in patients with prostate cancer. Methylphenidate is a type of central nervous system stimulant that can improve cognitive ability, mainly in memory and cognitive function. Exercise can improve mood and the physical aspects of cancer-related fatigue. Giving methylphenidate in combination with exercise may work better in reducing cancer-related fatigue in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine if the combination of exercise (EX) plus methylphenidate (MP) is superior to exercise plus placebo in the treatment of cancer-related fatigue (CRF) in patients with prostate cancer scheduled to receive radiotherapy with androgen deprivation therapy for 12 weeks.
SECONDARY OBJECTIVE:
I. To determine the effects of combined exercise plus methylphenidate on quality-of-life, mood, physical, and cognitive measures.
EXPLORATORY OBJECTIVES:
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
- Male
- 接受健康志愿者
- 否
入选标准
- •* Have a diagnosis of prostate cancer and be scheduled to receive radiotherapy with concurrent androgen deprivation therapy, and presence of fatigue with severity of 1/10, on a 0-10 scale for at least 2 weeks
- •* Patient not regularly engaging in moderate aerobic exercise for \>90 minutes/week and/or vigorous aerobic exercise for \>30 minutes/week, and/ or strength training for \>/= 1 day/week
- •* Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of \/= 10 g/dL within 2 weeks of enrollment
- •* Be able to understand the description of the study and give written informed consent
- •* Have a Zubrod performance status score of 0 to 2
- •* Seen at an outpatient clinic at MD Anderson Cancer Center, its Houston Area Locations (HALs) or Smith Radiation Oncology Clinic (HHS)
排除标准
- •Have a major contraindication to MethylphenidateMP) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), or conditions making adherence difficult as determined by the attending physician
- •Be currently taking MP, or have taken it within the previous 10 days
- •Be unable to complete the baseline assessment forms (e.g., due to language or sensory barriers) or to understand the recommendations for participation in the study
- •Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
- •Have glaucoma
- •Have severe cardiac disease (New York Heart Association functional class III or IV)
- •Have tachycardia and/or uncontrolled hypertension
- •Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantone, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
研究组 & 干预措施
Group I (methylphenidate, resistance training, walking)
Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
干预措施: Questionnaire Administration (Other)
Group III (methylphenidate, stretching)
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group III (methylphenidate, stretching)
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Questionnaire Administration (Other)
Group IV (placebo, stretching)
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group II (placebo, resistance training, stretching)
Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
干预措施: Exercise Intervention (Behavioral)
Group II (placebo, resistance training, stretching)
Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
干预措施: Questionnaire Administration (Other)
Group III (methylphenidate, stretching)
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Stretching (Other)
Group IV (placebo, stretching)
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Stretching (Other)
Group I (methylphenidate, resistance training, walking)
Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
干预措施: Exercise Intervention (Behavioral)
Group II (placebo, resistance training, stretching)
Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
干预措施: Placebo (Other)
Group II (placebo, resistance training, stretching)
Patients receive a placebo PO BID and undergo exercise program consisting of resistance training BIW and walking 15-40 minutes a day for 4 days a week for 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group IV (placebo, stretching)
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Placebo (Other)
Group I (methylphenidate, resistance training, walking)
Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group IV (placebo, stretching)
Patients receive a placebo PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Questionnaire Administration (Other)
Group I (methylphenidate, resistance training, walking)
Patients receive methylphenidate PO BID and undergo exercise program consisting of resistance training BIW and walking 15- 40 minutes a day 4 days a week for 12 weeks.
干预措施: Methylphenidate (Drug)
Group III (methylphenidate, stretching)
Patients receive methylphenidate PO BID and undergo stretching for 4 days a week for 12 weeks.
干预措施: Methylphenidate (Drug)
结局指标
主要结局
Level of cancer-related fatigue in all groups
时间窗: Up to 12 weeks
Will measure cancer-related fatigue (CRF) using the area under the curve (AUC) of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale score. The intervention exposure will be operationalized as proportion of the total minutes of prescribed exercise intervention the study patient was actually able to participate, or the proportion of prescribed study medication the study patient was able to actually take.
次要结局
- Change in quality of life, mood, physical and cognitive measures in all groups(Baseline up to 12 weeks)