A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Assessment of the effects of methylphenidate (MP) plus physical activity in reducing cancer-related fatigue (CRF)
研究概览
简要总结
This phase III trial studies how well methylphenidate and physical activity works in reducing cancer-related fatigue in patients who are receiving anti-PD1 immunotherapy for cancer that has spread to other places in the body. Central nervous systems stimulants, such as methylphenidate, may help to improve cognitive function. Physical activity uses techniques, such as aerobic and resistance exercises, which may help to improve quality of life. Giving methylphenidate and physical activity may help in reducing cancer-related fatigue in patients with metastatic cancer who receive anti-PD1 immunotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effects of methylphenidate plus physical activity (MP) compared to placebo plus physical activity (PL) in reducing cancer-related fatigue (CRF) in patients with metastatic cancer on anti-PD1 immunotherapy, as measured by changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale scores after 2 weeks of intervention.
SECONDARY OBJECTIVES:
I. To explore the effect of MP on anxiety (Hospital Anxiety and Depression Scale [HADS]), depressed mood (HADS), cancer symptoms (Edmonton Symptom Assessment Scale (ESAS), physical activity (mean day time activity as measured by actigraphy), and serum levels of inflammatory cytokines (IL-1beta, IL-1 RA, IL-6, TNF-alpha, IL-8, IL-10, and MCP1), before and after treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Part 1: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment
- •Part 1: be willing to engage in follow-up telephone calls with a research staff
- •Part 1: have telephone access so they can be contacted by the research staff
- •Part 1: hemoglobin level of >= 8 g/dL within 2 weeks of enrollment
- •* Packed red blood cell (PRBC) transfusions will be allowed to patients with hemoglobin < 8 g/dl
- •Part 1: be able to understand the description of the study and give written informed consent
- •Part 1: able to read, write and speak English
- •Part 2: have a diagnosis of metastatic or recurrent cancer and previously received anti PD1 immunotherapy provided that they received therapy up to 1 month prior to enrollment
- •Part 2: be willing to engage in follow-up telephone calls with a research staff
- •Part 2: have telephone access so they can be contacted by the research staff
- •Part 2: have a hemoglobin level of >=8 g/dL within 2 weeks of enrollment
- •* PRBC transfusions will be allowed to patients with hemoglobin < 8 g/dl
- •Part 2: be able to understand the description of the study and give written or verbal informed consent
- •Part 2: able to read, write and speak English
- •Part 2: presence of fatigue as defined FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
- •Part 2: not currently taking methylphenidate, or have taken it within the previous 10 days
- •Part 2: able to complete the baseline assessment forms
- •Part 2: able to understand the recommendations for participation in the study
- •Part 2: can be enrolled directly to part 2 independent of part 1 if on immunotherapy and having a FACIT-F fatigue =< 34, and able to complete baseline assessment and bloodwork as detailed in Part 1 at baseline and day 14 +/-3 days. Treating Oncologist should agree for participation in the intervention trial
排除标准
- •Part 1: patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference
- •Part 2: Patients will be excluded if (1) have clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale score of >= 13 at baseline completed in person, by phone, or via video-conference
- •Part 2: have a major contraindication to MP (e.g., allergy/hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician
- •Part 2: on monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
- •Part 2: history of glaucoma
- •Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV)
- •Part 2: tachycardia and/or uncontrolled hypertension
- •Part 2: currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
- •Part 2: patients with Cut Down, Annoyed, Guilty and Eye Opener-Adapted to Include Drugs (CAGE-AID) >= 2
研究组 & 干预措施
ARM I (methylphenidate, physical activity)
Patients receive methylphenidate PO BID for up to 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete physical activity consisting of walking and resistance exercise over 25-40 minutes QD 4 days a week. After 2 weeks, patients may continue methylphenidate at the discretion of the treating physician for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Physical Activity (Other)
ARM II (placebo, physical activity)
Patients receive a matched placebo PO BID and complete physical activity as in Arm I. Treatment continues for up to 2 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
ARM II (placebo, physical activity)
Patients receive a matched placebo PO BID and complete physical activity as in Arm I. Treatment continues for up to 2 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
ARM II (placebo, physical activity)
Patients receive a matched placebo PO BID and complete physical activity as in Arm I. Treatment continues for up to 2 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
ARM I (methylphenidate, physical activity)
Patients receive methylphenidate PO BID for up to 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete physical activity consisting of walking and resistance exercise over 25-40 minutes QD 4 days a week. After 2 weeks, patients may continue methylphenidate at the discretion of the treating physician for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
ARM I (methylphenidate, physical activity)
Patients receive methylphenidate PO BID for up to 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete physical activity consisting of walking and resistance exercise over 25-40 minutes QD 4 days a week. After 2 weeks, patients may continue methylphenidate at the discretion of the treating physician for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
ARM II (placebo, physical activity)
Patients receive a matched placebo PO BID and complete physical activity as in Arm I. Treatment continues for up to 2 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Physical Activity (Other)
ARM II (placebo, physical activity)
Patients receive a matched placebo PO BID and complete physical activity as in Arm I. Treatment continues for up to 2 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo (Other)
ARM I (methylphenidate, physical activity)
Patients receive methylphenidate PO BID for up to 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete physical activity consisting of walking and resistance exercise over 25-40 minutes QD 4 days a week. After 2 weeks, patients may continue methylphenidate at the discretion of the treating physician for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
ARM I (methylphenidate, physical activity)
Patients receive methylphenidate PO BID for up to 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete physical activity consisting of walking and resistance exercise over 25-40 minutes QD 4 days a week. After 2 weeks, patients may continue methylphenidate at the discretion of the treating physician for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Methylphenidate (Drug)
结局指标
主要结局
Assessment of the effects of methylphenidate (MP) plus physical activity in reducing cancer-related fatigue (CRF)
时间窗: Up to 12 weeks
Effects of MP to be compared to placebo plus physical activity results. To be as measured by changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) sub-scale scores. A t test will be used to evaluate the difference between groups unless the data appear to be non-normally distributed, in which case a Wilcoxon rank-sum test will be used to evaluate the difference between groups.
次要结局
- Assessment of MP effects on physical activity(Up to 12 weeks)
- Assessment of MP effects on anxiety, depressed mood, and cancer symptoms by questionnaires(Up to 5 minutes during visit)