Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores
研究概览
简要总结
The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied.
Methylphenidate is a stimulant designed to increase the activity of the central nervous system.
A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
The exercise in this study is designed to help improve your physical fitness and energy levels.
Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.
详细描述
If you are found eligible and agree to take part in the study:
- You will complete a baseline exercise assessment which will last about 30-45 minutes and include the following:
- A sit-to-stand test. You will sit in chair with your arms across your chest. Then you will be timed as you stand and sit down 5 times as quickly as possible.
- A hand-grip strength test. You will grip a device with each hand as hard as you can.
- A 6-minute walk test. You will be timed while you walk on a 100-foot loop. You will walk 50 feet and then turn and walk back to the beginning. You will do this at a walking speed that feels comfortable and for as many times as you can in 6 minutes.
- You will be given a belt (accelerometer) that you are required to wear for the first week of treatment. The accelerometer measures your physical activity.
Study Groups:
You will be randomly assigned (as in the roll of dice) to 1 of 8 study groups. You will have an equal chance of being assigned to any group. You will have a 50% chance of receiving the placebo.
The exercises and skills learned during counseling will be different for each study group. The study staff will talk to you about your assigned exercises and skills. You will be assigned to 1 of 2 types of exercise groups. One group will do resistance exercises and walking, and the other group will do stretching.
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
- 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 are scheduled to receive radiotherapy with androgen deprivation therapy
- •Rate fatigue at least 1 or higher on a scale of 0-
- •Describe fatigue as being present every day for most of day for a minimum of 2 weeks.
- •Have no clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) 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 of 0 to 2.
排除标准
- •Have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician.
- •Be currently taking MP or have taken it within the previous 10 days.
- •Are regularly engaged in moderate- or vigorous-intensity exercise for at least 150 minutes per week.
- •Regularly used cognitive behavioral therapy in the last 6 weeks.
- •Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- •Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.
- •Have glaucoma.
- •Have with history of severe cardiac disease (New York Heart Association functional class III or IV).
- •Have tachycardia and/or uncontrolled hypertension
- •Be currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
- •History of uncontrolled hypothyroidism as evidenced by thyroid test (TSH) within the last month, hypercalcemia or hyperglycemia (within the last 15 days).
- •Unable to speak and understand English
- •Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study.
研究组 & 干预措施
Placebo + Sham Exercise
Placebo capsules by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
干预措施: Counseling Sessions (Behavioral)
Methylphenidate + Sham Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
干预措施: Counseling Sessions (Behavioral)
Cognitive Therapy + Placebo
Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily.
干预措施: Placebo (Other)
Cognitive Therapy + Placebo
Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily.
干预措施: Sham Exercise (Other)
Methylphenidate + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
干预措施: Sham Exercise (Other)
Methylphenidate + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
干预措施: Cognitive Behavioral Therapy (CBT) (Other)
Exercise + Cognitive Therapy + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily
干预措施: Cognitive Behavioral Therapy (CBT) (Other)
Methylphenidate + Sham Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
干预措施: Sham Exercise (Other)
Placebo + Sham Exercise
Placebo capsules by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
干预措施: Sham Exercise (Other)
Exercise + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Placebo capsules by mouth twice daily.
干预措施: Placebo (Other)
Exercise + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Placebo capsules by mouth twice daily.
干预措施: Counseling Sessions (Behavioral)
Exercise + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Placebo capsules by mouth twice daily.
干预措施: Standardized Exercise Intervention Program (Other)
Cognitive Therapy + Placebo
Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily.
干预措施: Cognitive Behavioral Therapy (CBT) (Other)
Methylphenidate + Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
干预措施: Standardized Exercise Intervention Program (Other)
Exercise + Cognitive Therapy + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily
干预措施: Placebo (Other)
Exercise + Cognitive Therapy + Placebo
Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily
干预措施: Standardized Exercise Intervention Program (Other)
Methylphenidate + Exercise + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
干预措施: Standardized Exercise Intervention Program (Other)
Methylphenidate + Exercise + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
干预措施: Cognitive Behavioral Therapy (CBT) (Other)
Placebo + Sham Exercise
Placebo capsules by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
干预措施: Placebo (Other)
Methylphenidate + Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
干预措施: Counseling Sessions (Behavioral)
Methylphenidate + Sham Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
干预措施: Methylphenidate (Drug)
Methylphenidate + Exercise
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
干预措施: Methylphenidate (Drug)
Methylphenidate + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
干预措施: Methylphenidate (Drug)
Methylphenidate + Exercise + Cognitive Therapy
Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
干预措施: Methylphenidate (Drug)
结局指标
主要结局
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores
时间窗: Baseline and on Day 57
Effects of various treatments\[exercise, Cognitive Behavioral Therapy (CBT), Methylphenidate\] and combinations of treatments in Multimodal Therapy (MMT) in reducing cancer-related fatigue in participants with prostate cancer receiving radiotherapy (RT), as measured by change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores taken at baseline and on Day 57.
次要结局
未报告次要终点