Prostate Cancer Clinical Trial
Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients
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.
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.
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
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).
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There is 1 Location for this study
San Antonio Texas, 78229, United States More Info
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