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NCT05054296RecruitingPhase 2

Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring

Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring

Source: ClinicalTrials.gov · Last updated 29 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
6 Jan 2020
Start date
23 Mar 2020
Primary completion date
2 Feb 2027
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT05054296

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 23 Mar 2020 to the primary completion date, 2 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Radiation therapy or surgical intervention for prior bone metastasis

Other illness

  • 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
  • Clinically significant active malignancy other than prostate cancer
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness

Lab values

  • 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

Other

  • Symptomatic bone metastasis
  • Any investigational pharmaceutical products
  • Untreated symptomatic spinal cord compressions
  • Prisoners or subjects who are involuntarily incarcerated

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.