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

Primary Purpose

Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Exercise Intervention
FitBit
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Biochemically Recurrent Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (education exercise packet, FitBit)

Group II (exercise program FitBit)

Arm Description

Patients 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.

Patients 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 6, 2020
Last Updated
March 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05054296
Brief Title
Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring
Official Title
Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
February 2, 2027 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVE: I. Determine the relationship between a 16-week exercise program with continuous Fitbit monitoring and cardiovascular fitness (defined by change in 10-year atherosclerotic cardiovascular disease [ASCVD] risk score), as compared to Fitbit monitoring alone, in prostate cancer patients on androgen deprivation therapy (ADT). SECONDARY OBJECTIVES: I. Determine the length of cardiovascular fitness effect (measured using 10-year ASCVD risk 12 weeks post intervention) for a 16-week exercise program with continuous Fitbit monitoring in prostate cancer patients on ADT. II. Screen for a relationship between a 16-week exercise program with continuous Fitbit monitoring and metabolic syndrome severity (defined by change in metabolic severity index z-score), as compared to Fitbit monitoring alone, in prostate cancer patients on ADT. III. Measure the relationship between the exercise intervention and prostate-specific antigen (PSA) velocity, compared to Fitbit monitoring alone. IV. Measure the relationship between the exercise intervention and physical fitness (using V02 and body composition), compared to Fitbit monitoring alone. V. Measure the relationship between the exercise intervention and physical activity (step count)/heart rate, compared to Fitbit monitoring alone. VI. Measure the relationship between the exercise intervention and physical activity (as measured by the Godin Leisure Time Physical Activity Questionnaire) compared to Fitbit monitoring alone. VII. Measure the relationship between the exercise intervention and, quality of life/symptom burden, compared to Fitbit monitoring alone (measured by the following patient reported surveys: National Cancer Institute-patient reported outcomes-Common Terminology Criteria for Adverse Events [NCI-PRO-CTCAE], Patient Reported Outcomes Measurement Information System [PROMIS] Fatigue and Physical Function, Self Efficacy, European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core30 [QLQ-C30] and Prostate Cancer 25 [PR25]). EXPLORATORY OBJECTIVE: I. Explore the relationship between the exercise intervention and markers of insulin resistance, inflammation/immune function and metabolism utilizing pre- and post-intervention peripheral blood analysis. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients 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: Patients participate in supervised and self-directed exercise sessions over 60 minutes twice a week (BIW) for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (education exercise packet, FitBit)
Arm Type
Active Comparator
Arm Description
Patients 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.
Arm Title
Group II (exercise program FitBit)
Arm Type
Experimental
Arm Description
Patients 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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive general education exercise packet
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Participate in supervised and self-directed exercise sessions
Intervention Type
Device
Intervention Name(s)
FitBit
Intervention Description
Wear FitBit for activity tracking
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Atherosclerotic cardiovascular disease (ASCVD) 10-year risk score
Description
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
Time Frame
Through the study completion, an average of a year.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher J Logothetis
Phone
7135637210
Email
clogothe@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Logothetis
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher J. Logothetis
Phone
713-792-2830
First Name & Middle Initial & Last Name & Degree
Christopher J. Logothetis

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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