Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
2 other identifiers
interventional
200
1 country
1
Brief Summary
This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedStudy Start
First participant enrolled
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
March 29, 2023
March 1, 2023
6.9 years
January 6, 2020
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score
The 16-week exercise program would affect this risk score through reduction of systolic blood pressure (SBP) and cholesterol while increasing high-density lipoprotein (HDL). · A 0 to 4.9 percent risk is considered low. Eating a healthy diet and exercising will help keep your risk low. Medication is not recommended unless your LDL, or "bad" cholesterol, is greater than or equal to 190. * A 5 to 7.4 percent risk is considered borderline. Use of a statin medication may be recommended if you have certain conditions, or "risk enhancers." These conditions may increase your risk of a heart disease or stroke. Talk with your primary care provider to see if you have any of the risk enhancers in the list below. * A 7.5 to 20 percent risk is considered intermediate. It is recommended that you start with moderate-intensity statin therapy. * A greater than 20 percent risk is considered high. It is recommended that you start with high-intensity statin therapy
Through the study completion, an average of a year.
Study Arms (2)
Group I (education exercise packet, FitBit)
ACTIVE COMPARATORPatients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks.
Group II (exercise program FitBit)
EXPERIMENTALPatients participate in supervised and self-directed exercise sessions over 60 minutes BIW for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.
Interventions
Receive general education exercise packet
Participate in supervised and self-directed exercise sessions
Wear FitBit for activity tracking
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \[CT\] and/or magnetic resonance imaging \[MRI\]) or biochemical recurrence/refractoriness following local therapy (prostatectomy or radiation)
- Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months
- On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months
- Combination ADT with abiraterone or enzalutamide is permitted
- Anticipation to remain hypogonadal for at least 6 months subsequently
- Asymptomatic bone metastasis is permissible (exercise will be modified and patients monitored)
- Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol \^70 supervised by a cardiologist
- Hemoglobin \>= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment
- Platelet count \>=75,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment
- Access to a smart phone with android or iPhone OS (iOS) operating systems
- Able to speak and comprehend English
You may not qualify if:
- Current use of any other systemic therapy for prostate cancer with the exception of gonadotrophin releasing hormone (GnRH) agonists/antagonists, abiraterone, enzalutamide, bisphosphonates or RANK-ligand inhibitors (for bone metastases) which are allowed
- Any underlying comorbid medical or psychiatric condition, which in the opinion of the Investigator, will make participation in our exercise intervention hazardous or obscure the interpretation of adverse events
- Inability to walk 400 meters or undertake upper and lower limb exercise, and resistance training in the previous 3 months
- Chemotherapy treatment within 28 days of study enrollment
- Symptomatic bone metastasis
- Any investigational pharmaceutical products
- Radiation therapy or surgical intervention for prior bone metastasis
- Clinically significant active malignancy other than prostate cancer
- Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\>= 450 m/sec)
- Clinically significant heart disease that may impact safety of independent or supervised exercise including preexisting coronary artery disease, myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of \< 40% at baseline
- Untreated symptomatic spinal cord compressions
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher J Logothetis
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2020
First Posted
September 23, 2021
Study Start
March 23, 2020
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
March 29, 2023
Record last verified: 2023-03