Pilot Study of a Randomized Chemo-periodized Adjuvant High-Intensity Interval Training Intervention to Improve Chemotherapy Tolerance in Men With Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Docetaxel chemotherapy toxicity
研究概览
简要总结
This study aims to examine the use of high-intensity interval training (HIIT) and resistance training on docetaxel chemotherapy tolerability and toxicity in metastatic prostate cancer.
详细描述
Exercise has been shown to decrease tumor progression and mitigate treatment-related side effects, such as fatigue, while increasing physical fitness. In this study, investigators will test the effects of a high intensity interval training and resistance exercise program on how patients with metastatic prostate cancer tolerate docetaxel chemotherapy. Participants assigned to the exercise intervention will be asked to meet with a personal trainer 2-3 times per week for supervised exercise sessions. All participants will be asked to complete electronic questionnaires during their chemotherapy sessions that ask about their physical and mental wellbeing.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessments and analysis will be done by study staff blinded to the participant allocation
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
- •Diagnosis of metastatic prostate cancer
- •Includes metastatic hormone sensitive prostate cancer, AND
- •Metastatic castration resistant prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Planned to receive docetaxel chemotherapy for treatment of prostate cancer with plan for at least 4 cycles of therapy
- •Estimated life expectancy > 6 months
- •Must be receiving androgen deprivation therapy (ADT) during study period or have had prior bilateral orchiectomy
- •4 weeks from any major surgery
- •Age > 18 years
- •Willing to participate in exercise intervention per protocol
- •Cleared by study personnel to participate in exercise intervention based on screening physical exam
- •Eligible patients can be participating in other investigational protocols or consent to other investigational protocols during this study participation if it does not affect docetaxel dosing, include additional cytotoxic chemotherapy, or interfere with exercise intervention
- •Patients must be able to travel to one of the study-designated exercise facilities up to three days per week
- •Required Initial Laboratory Values:
- •Absolute neutrophil count (12) ≥ 1500/uL
- •Platelet count ≥ 100,000/uL
- •Creatinine ≤ 1.5 x upper limits of normal
- •Bilirubin ≤ 1.5 x upper limits of normal
- •Aspartate aminotransferase (AST) ≤ 1.5 x upper limits of normal
- •Serum testosterone ≤ 50 ng/dL
排除标准
- •Known small cell neuroendocrine cancer of the prostate
- •Has already initiated first-line chemotherapy treatment course
- •Poorly controlled hypertension, BP >160/90 on >1 occasion during screening period
- •NYHA Class II heart failure
- •Serious cardiovascular event within 6 months of consent, including transient ischemic attack, cerebrovascular accident, or myocardial infarction
- •Receiving additional cytotoxic chemotherapy in addition to docetaxel during study participation
- •Stable or unstable angina
- •Active second malignancy, with exception of non-melanoma skin cancer or non-invasive bladder cancer
- •Known physical limitation that would impede participation in exercise per protocol
- •Moderate-to-severe bone pain (i.e NCI common terminology criteria of adverse events grade 2-3 bone pain)
- •Men already participating in vigorous aerobic exercise for more than 60 minutes per day or structured resistance exercise (>2 upper body and >2 lower body exercises) 2 or more days a week.
- •Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol.
- •Has chest pain during physical activity (patient can participate with cardiologist clearance).
- •Uncontrolled asthma (patient can participate if on asthma controlling medications and has access to rescue inhaler).
研究组 & 干预措施
Exercise Intervention
Participants will engage in 2-3 supervised high intensity aerobic and resistance exercise sessions per week.
干预措施: High Intensity Interval Training (Other)
Control
Participants will continue daily routine as usual and given an informational flyer on physical activity and cancer.
结局指标
主要结局
Docetaxel chemotherapy toxicity
时间窗: 2 years
Rates of CT CAE v.5 reported symptoms related to treatment
Functional assessment of Cancer therapy (FACT)-Taxane subscale
时间窗: Baseline to 2 years
Change in score on a 16 point scale using a 5-point response scale focused on patient-reported neuropathic symptoms and concerns: 0 =Not at all 1. =A little bit 2. =Somewhat 3. =Quite a bit 4. =Very much Range of scores is from 0-64 with a lower score indicating less neuropathic symptoms and concerns.
Docetaxel chemotherapy tolerability
时间窗: 2 years
Number of Changes or delays in docetaxel treatment schedule or dosing (tolerability)
次要结局
- Godin Leisure(Baseline to 2 years)
- Functional assessment of Cancer therapy (FACT)-G(Baseline to 2 years)
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Baseline to 2 years)
- European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(Baseline to 2 years)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline to 2 years)