Back to resultsDebunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Primary Purpose
PROSTATE CANCER, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised Circuit Training
Sponsored by
About this trial
This is an interventional supportive care trial for PROSTATE CANCER focused on measuring Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria: Ability to understand and the willingness to sign informed consent prior to any study-related procedures. Diagnosed with metastatic prostate cancer. Aged ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included. Have been receiving androgen deprivation (either with or without androgen receptor targeted treatment) for at least one month and expect to remain on their treatment for at least 4 months. Are pre-frail or frail as indicated by the FRAIL scale (a score of 1-2 = pre-frail; 3-5 = frail). Have physician's clearance to participate in exercise. Speak English. Participate in less than 2 structured resistance exercise sessions per week over the last 4 months. Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month. Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions. Exclusion Criteria: Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects. Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures. Complete 2 or more structured resistance exercise sessions per week over the last 4 months and participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current exercise program. Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded. Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects. Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
Sites / Locations
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exercise Group
Attention Control Group
Arm Description
Participants will partake in a 16-week supervised exercise program.
Participants will continue with their normal daily activities.
Outcomes
Primary Outcome Measures
Change in Circulating Inflammation for Exercise Group
Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).
Frailty
This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.
Secondary Outcome Measures
Sarcopenia
A sarcopenia score of ≤10.75 kg/m2, as assessed by computed tomography (CT), will be the cut point used for identifying muscle loss = 1 point.
Skeletal Muscle Biomarkers - myokines
Assessed from muscle biopsy specimens of the vastus lateralis (ul/ml).
Full Information
NCT ID
NCT06040125
First Posted
August 10, 2023
Last Updated
September 13, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Prostate Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT06040125
Brief Title
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Official Title
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Prostate Cancer Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT).
The names of the study intervention involved in this study is:
• Supervised circuit training (aerobic and resistance exercise regimen)
Detailed Description
This research study is a pilot, randomized control study, which is the first-time investigators are examining this intervention in this setting.
Participants will be randomized into one of two study groups: Exercise Group versus Attention Control Group. Randomization means a participant is placed into a group by chance.
The research study procedures include screening for eligibility, study treatment, including extensive evaluations of fitness, physical health and strength, blood tests, muscle biopsy, surveys, and follow-up visits.
Participation in this research study is expected to last about 16 weeks.
It is expected that about 80 people will take part in this research study.
The Prostate Cancer Foundation is providing funding for this research study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PROSTATE CANCER, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma
Keywords
Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Participants will partake in a 16-week supervised exercise program.
Arm Title
Attention Control Group
Arm Type
Experimental
Arm Description
Participants will continue with their normal daily activities.
Intervention Type
Behavioral
Intervention Name(s)
Supervised Circuit Training
Intervention Description
16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.
Primary Outcome Measure Information:
Title
Change in Circulating Inflammation for Exercise Group
Description
Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).
Time Frame
Baseline (week 0) and Post-intervention (week 17)
Title
Frailty
Description
This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.
Time Frame
Baseline (week 0) and Post-intervention (week 17)
Secondary Outcome Measure Information:
Title
Sarcopenia
Description
A sarcopenia score of ≤10.75 kg/m2, as assessed by computed tomography (CT), will be the cut point used for identifying muscle loss = 1 point.
Time Frame
Baseline (week 0) and Post-intervention (week 17)
Title
Skeletal Muscle Biomarkers - myokines
Description
Assessed from muscle biopsy specimens of the vastus lateralis (ul/ml).
Time Frame
Baseline (week 0) and Post-intervention (week 17)
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
Diagnosed with metastatic prostate cancer.
Aged ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included.
Have been receiving androgen deprivation (either with or without androgen receptor targeted treatment) for at least one month and expect to remain on their treatment for at least 4 months.
Are pre-frail or frail as indicated by the FRAIL scale (a score of 1-2 = pre-frail; 3-5 = frail).
Have physician's clearance to participate in exercise.
Speak English.
Participate in less than 2 structured resistance exercise sessions per week over the last 4 months.
Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month.
Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
Exclusion Criteria:
Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects.
Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures.
Complete 2 or more structured resistance exercise sessions per week over the last 4 months and participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current exercise program.
Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects.
Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dieli-Conwright, MD
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Einstein, MD
Phone
617-667-1957
Email
Deinstei@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
David Einstein, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, MD
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Learn more about this trial
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
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