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Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients (HIIT PCa)

Primary Purpose

Prostate Cancer Metastatic, Castrate Resistant Prostate Cancer, Metastatic Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Training
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring metastatic prostate cancer, high-intensity interval training, HIIT, exercise, exercise oncology, resistance training

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of metastatic prostate cancer

    • Includes metastatic hormone sensitive prostate cancer, AND
    • Metastatic castration resistant prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Planned to receive docetaxel chemotherapy for treatment of prostate cancer with plan for at least 4 cycles of therapy
  • Estimated life expectancy > 6 months
  • Must be receiving androgen deprivation therapy (ADT) during study period or have had prior bilateral orchiectomy
  • 4 weeks from any major surgery
  • Age > 18 years
  • Willing to participate in exercise intervention per protocol
  • Cleared by study personnel to participate in exercise intervention based on screening physical exam
  • Eligible patients can be participating in other investigational protocols or consent to other investigational protocols during this study participation if it does not affect docetaxel dosing, include additional cytotoxic chemotherapy, or interfere with exercise intervention
  • Patients must be able to travel to one of the study-designated exercise facilities up to three days per week

  • Required Initial Laboratory Values:

    • Absolute neutrophil count (12) ≥ 1500/uL
    • Platelet count ≥ 100,000/uL
    • Creatinine ≤ 1.5 x upper limits of normal
    • Bilirubin ≤ 1.5 x upper limits of normal
    • Aspartate aminotransferase (AST) ≤ 1.5 x upper limits of normal
    • Serum testosterone ≤ 50 ng/dL

Exclusion Criteria:

  • Known small cell neuroendocrine cancer of the prostate
  • Has already initiated first-line chemotherapy treatment course
  • Poorly controlled hypertension, BP >160/90 on >1 occasion during screening period
  • NYHA Class II heart failure
  • Serious cardiovascular event within 6 months of consent, including transient ischemic attack, cerebrovascular accident, or myocardial infarction
  • Receiving additional cytotoxic chemotherapy in addition to docetaxel during study participation
  • Stable or unstable angina
  • Active second malignancy, with exception of non-melanoma skin cancer or non-invasive bladder cancer
  • Known physical limitation that would impede participation in exercise per protocol
  • Moderate-to-severe bone pain (i.e NCI common terminology criteria of adverse events grade 2-3 bone pain)
  • Men already participating in vigorous aerobic exercise for more than 60 minutes per day or structured resistance exercise (>2 upper body and >2 lower body exercises) 2 or more days a week.
  • Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol.
  • Has chest pain during physical activity (patient can participate with cardiologist clearance).
  • Uncontrolled asthma (patient can participate if on asthma controlling medications and has access to rescue inhaler).

Sites / Locations

  • UT Health San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Intervention

Control

Arm Description

Participants will engage in 2-3 supervised high intensity aerobic and resistance exercise sessions per week.

Participants will continue daily routine as usual and given an informational flyer on physical activity and cancer.

Outcomes

Primary Outcome Measures

Docetaxel chemotherapy tolerability
Number of Changes or delays in docetaxel treatment schedule or dosing (tolerability)
Docetaxel chemotherapy toxicity
Rates of CT CAE v.5 reported symptoms related to treatment
Functional assessment of Cancer therapy (FACT)-Taxane subscale
Change in score on a 16 point scale using a 5-point response scale focused on patient-reported neuropathic symptoms and concerns: 0 =Not at all =A little bit =Somewhat =Quite a bit =Very much Range of scores is from 0-64 with a lower score indicating less neuropathic symptoms and concerns.

Secondary Outcome Measures

Functional assessment of Cancer therapy (FACT)-G
Change in FACIT-G score. FACT-G contains four subscales measuring physical well being, social well-being, emotional well-being, and functional well being containing 7,7,6, and 7 items respectively. Responses to questions are scored: 0 =Not at all =A little bit =Somewhat =Quite a bit =Very much Scores from the 4 scales are added to give a total score between 0-108, where a lower score indicates better physical, social, emotional and functional well-being.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Change in score on this subscale, which contains 13 items assessing the consequences of fatigue. Each item is rated on a 5-point Likert scale ranging from 0=not at all to 4=very much. Totals range from 0-52 with a lower score indicating less fatigue.
European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Change in score for 30 questions to assess the quality of life with 9 multi-item scales: 5 functional scales; 3 symptom scales; and a global health and quality-of-life (GHQL) scale. A few 1-item symptom measures are included. Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (GHQL and the Financial Impact scale are not included). Prior to calculating the mean, the symptom scales are reversed to obtain a uniform direction of all scales. All scales and 1-item measures range from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Pittsburgh Sleep Quality Index (PSQI)
Change in score on this 19-question assessment will be used to assess sleep quality and sleep habits. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Godin Leisure
Change in score calculated using the following formula: Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The first 3 questions relate to type of activity and the 4th to number of times a week the activity is engaged in for at least 15 minutes. EXAMPLE Strenuous = 3 times/wk Moderate = 6 times/wk Light = 14 times/wk Total leisure activity score = (9 × 3) + (5 × 6) + (3 × 14) = 27 + 30 + 42 = 99 Godin Scale Score: Interpretation 24 units or more: Active 14-23 units: Moderately Active Less than 14 units: Insufficiently Active/Sedentary

Full Information

First Posted
September 29, 2021
Last Updated
October 2, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT05156372
Brief Title
Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients
Acronym
HIIT PCa
Official Title
Pilot Study of a Randomized Chemo-periodized Adjuvant High-Intensity Interval Training Intervention to Improve Chemotherapy Tolerance in Men With Metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

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 study aims to examine the use of high-intensity interval training (HIIT) and resistance training on docetaxel chemotherapy tolerability and toxicity in metastatic prostate cancer.
Detailed Description
Exercise has been shown to decrease tumor progression and mitigate treatment-related side effects, such as fatigue, while increasing physical fitness. In this study, investigators will test the effects of a high intensity interval training and resistance exercise program on how patients with metastatic prostate cancer tolerate docetaxel chemotherapy. Participants assigned to the exercise intervention will be asked to meet with a personal trainer 2-3 times per week for supervised exercise sessions. All participants will be asked to complete electronic questionnaires during their chemotherapy sessions that ask about their physical and mental wellbeing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic, Castrate Resistant Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Adenocarcinoma
Keywords
metastatic prostate cancer, high-intensity interval training, HIIT, exercise, exercise oncology, resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessments and analysis will be done by study staff blinded to the participant allocation
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
Participants will engage in 2-3 supervised high intensity aerobic and resistance exercise sessions per week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will continue daily routine as usual and given an informational flyer on physical activity and cancer.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training
Other Intervention Name(s)
HIIT
Intervention Description
Participants will perform high-intensity aerobic and resistance exercise
Primary Outcome Measure Information:
Title
Docetaxel chemotherapy tolerability
Description
Number of Changes or delays in docetaxel treatment schedule or dosing (tolerability)
Time Frame
2 years
Title
Docetaxel chemotherapy toxicity
Description
Rates of CT CAE v.5 reported symptoms related to treatment
Time Frame
2 years
Title
Functional assessment of Cancer therapy (FACT)-Taxane subscale
Description
Change in score on a 16 point scale using a 5-point response scale focused on patient-reported neuropathic symptoms and concerns: 0 =Not at all =A little bit =Somewhat =Quite a bit =Very much Range of scores is from 0-64 with a lower score indicating less neuropathic symptoms and concerns.
Time Frame
Baseline to 2 years
Secondary Outcome Measure Information:
Title
Functional assessment of Cancer therapy (FACT)-G
Description
Change in FACIT-G score. FACT-G contains four subscales measuring physical well being, social well-being, emotional well-being, and functional well being containing 7,7,6, and 7 items respectively. Responses to questions are scored: 0 =Not at all =A little bit =Somewhat =Quite a bit =Very much Scores from the 4 scales are added to give a total score between 0-108, where a lower score indicates better physical, social, emotional and functional well-being.
Time Frame
Baseline to 2 years
Title
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Description
Change in score on this subscale, which contains 13 items assessing the consequences of fatigue. Each item is rated on a 5-point Likert scale ranging from 0=not at all to 4=very much. Totals range from 0-52 with a lower score indicating less fatigue.
Time Frame
Baseline to 2 years
Title
European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Description
Change in score for 30 questions to assess the quality of life with 9 multi-item scales: 5 functional scales; 3 symptom scales; and a global health and quality-of-life (GHQL) scale. A few 1-item symptom measures are included. Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (GHQL and the Financial Impact scale are not included). Prior to calculating the mean, the symptom scales are reversed to obtain a uniform direction of all scales. All scales and 1-item measures range from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Time Frame
Baseline to 2 years
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Change in score on this 19-question assessment will be used to assess sleep quality and sleep habits. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time Frame
Baseline to 2 years
Title
Godin Leisure
Description
Change in score calculated using the following formula: Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The first 3 questions relate to type of activity and the 4th to number of times a week the activity is engaged in for at least 15 minutes. EXAMPLE Strenuous = 3 times/wk Moderate = 6 times/wk Light = 14 times/wk Total leisure activity score = (9 × 3) + (5 × 6) + (3 × 14) = 27 + 30 + 42 = 99 Godin Scale Score: Interpretation 24 units or more: Active 14-23 units: Moderately Active Less than 14 units: Insufficiently Active/Sedentary
Time Frame
Baseline to 2 years
Other Pre-specified Outcome Measures:
Title
Serum inflammatory biomarkers associated with tumor progression
Description
Compare changes in levels of serum measurements of biomarkers such as tumor necrosis factor alpha (pg/ml) and interleukins (pg/ml).
Time Frame
2 years
Title
Body Composition
Description
Compare changes in fat free mass and fat mass measured with dual energy x-ray absorptiometry (DEXA) scan from baseline to end-of-study
Time Frame
2 years
Title
Muscular Strength
Description
Compare changes in participant's 1 repetition maximum (1RM) weight between baseline and end-of-study for chest press, leg press, seated row, leg extension, and grip strength. Participants will lift progressively heavier weight in each exercise until unable to lift any extra weight. This will be recorded as the 1RM weight. Total load will be calculated across exercises, with higher load values indicating higher muscular strength.
Time Frame
2 years
Title
Aerobic Fitness
Description
Compare participant's time to completion on a 400 meter walk test from baseline to end-of-study. This submaximal test serves as a surrogate measure of aerobic fitness.
Time Frame
2 years
Title
Cognitive function changes over time
Description
Compare cognitive function changes between groups over time measured by Cambridge Neuropsychological Test Automated Battery (CANTAB).
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of metastatic prostate cancer Includes metastatic hormone sensitive prostate cancer, AND Metastatic castration resistant prostate cancer Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Planned to receive docetaxel chemotherapy for treatment of prostate cancer with plan for at least 4 cycles of therapy Estimated life expectancy > 6 months Must be receiving androgen deprivation therapy (ADT) during study period or have had prior bilateral orchiectomy 4 weeks from any major surgery Age > 18 years Willing to participate in exercise intervention per protocol Cleared by study personnel to participate in exercise intervention based on screening physical exam Eligible patients can be participating in other investigational protocols or consent to other investigational protocols during this study participation if it does not affect docetaxel dosing, include additional cytotoxic chemotherapy, or interfere with exercise intervention Patients must be able to travel to one of the study-designated exercise facilities up to three days per week Required Initial Laboratory Values: Absolute neutrophil count (12) ≥ 1500/uL Platelet count ≥ 100,000/uL Creatinine ≤ 1.5 x upper limits of normal Bilirubin ≤ 1.5 x upper limits of normal Aspartate aminotransferase (AST) ≤ 1.5 x upper limits of normal Serum testosterone ≤ 50 ng/dL Exclusion Criteria: Known small cell neuroendocrine cancer of the prostate Has already initiated first-line chemotherapy treatment course Poorly controlled hypertension, BP >160/90 on >1 occasion during screening period NYHA Class II heart failure Serious cardiovascular event within 6 months of consent, including transient ischemic attack, cerebrovascular accident, or myocardial infarction Receiving additional cytotoxic chemotherapy in addition to docetaxel during study participation Stable or unstable angina Active second malignancy, with exception of non-melanoma skin cancer or non-invasive bladder cancer Known physical limitation that would impede participation in exercise per protocol Moderate-to-severe bone pain (i.e NCI common terminology criteria of adverse events grade 2-3 bone pain) Men already participating in vigorous aerobic exercise for more than 60 minutes per day or structured resistance exercise (>2 upper body and >2 lower body exercises) 2 or more days a week. Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol. Has chest pain during physical activity (patient can participate with cardiologist clearance). Uncontrolled asthma (patient can participate if on asthma controlling medications and has access to rescue inhaler).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darpan I Patel, PhD
Phone
210-567-0362
Email
pateld7@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chethan Ramamurthy, MD
Phone
210-450-1132
Email
ramamurthyc@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darpan I Patel, PhD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darpan I Patel, PhD
Phone
210-567-0362
Email
pateld7@uthscsa.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients

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