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HIIT During Chemotherapy for Metastatic Prostate Cancer (HIIT PCa Trial)
N/A
Waitlist Available
Led By Darpan I Patel, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Diagnosis of metastatic prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
HIIT PCa Trial Summary
This trial will test if HIIT and resistance training can help people with metastatic prostate cancer better tolerate and recover from chemotherapy.
Who is the study for?
Men over 18 with metastatic prostate cancer, either hormone sensitive or castration resistant, who are starting docetaxel chemotherapy and have a life expectancy of more than 6 months. Participants must be able to perform high-intensity exercise and travel to the study's exercise facilities up to three times a week. Those with severe heart conditions, uncontrolled hypertension, recent major cardiovascular events, or other serious health issues that would limit exercise are excluded.Check my eligibility
What is being tested?
The trial is testing whether adding high-intensity interval training (HIIT) alongside resistance training can improve how well men with metastatic prostate cancer tolerate and respond to docetaxel chemotherapy.See study design
What are the potential side effects?
While this trial focuses on exercise as an intervention which typically has benefits like improved fitness and energy levels, potential side effects may include muscle soreness, fatigue, increased risk of injury if not done correctly, and possibly cardiovascular strain in those at risk.
HIIT PCa Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
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My condition is metastatic prostate cancer.
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My prostate cancer has spread and is not responding to hormone therapy.
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My prostate cancer has spread and responds to hormonal therapy.
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I am scheduled for at least 4 cycles of docetaxel chemotherapy for prostate cancer.
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I can go to a specific exercise facility up to three times a week.
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I am older than 18 years.
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I am currently on hormone therapy for cancer or have had both testicles removed.
HIIT PCa Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Docetaxel chemotherapy tolerability
Docetaxel chemotherapy toxicity
Functional assessment of Cancer therapy (FACT)-Taxane subscale
Secondary outcome measures
European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Functional assessment of Cancer therapy (FACT)-G
+2 moreOther outcome measures
Aerobic Fitness
Body Composition
Cognitive function changes over time
+2 moreHIIT PCa Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise InterventionExperimental Treatment1 Intervention
Participants will engage in 2-3 supervised high intensity aerobic and resistance exercise sessions per week.
Group II: ControlActive Control1 Intervention
Participants will continue daily routine as usual and given an informational flyer on physical activity and cancer.
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Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,414 Total Patients Enrolled
12 Trials studying Prostate Cancer
3,175 Patients Enrolled for Prostate Cancer
Darpan I Patel, PhDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
1 Previous Clinical Trials
20 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of the day.I have asthma but it's managed with medication and I always have a rescue inhaler.I can join other studies if they don't affect my current treatment or involve more chemotherapy.My condition is metastatic prostate cancer.My prostate cancer has spread and is not responding to hormone therapy.My prostate cancer has spread and responds to hormonal therapy.I experience moderate to severe bone pain.I already do more than 60 minutes of intense aerobic exercise daily or structured workouts twice a week.I experience chest pain when I'm active but have clearance from my cardiologist.I am scheduled for at least 4 cycles of docetaxel chemotherapy for prostate cancer.I can go to a specific exercise facility up to three times a week.I have been approved for exercise by the study team after a physical exam.I am older than 18 years.I have mild symptoms of heart failure.My prostate cancer is of the small cell neuroendocrine type.I have started my first round of chemotherapy.My blood pressure has been over 160/90 more than once recently.I have another cancer besides non-melanoma skin cancer or non-invasive bladder cancer.I have a physical condition that prevents me from exercising.It has been more than 4 weeks since my last major surgery.I am currently on hormone therapy for cancer or have had both testicles removed.I haven't had a stroke, heart attack, or similar event in the last 6 months.I have chest pain due to heart problems.I am taking other cancer-killing drugs besides docetaxel.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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