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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Recruiting

CT.gov ID

NCT05156372

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Metastatic Castrate Resistant Prostate Cancer Metastatic Prostate Cancer Metastatic Prostate Adenocarcinoma	Other: High Intensity Interval Training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessments and analysis will be done by study staff blinded to the participant allocation

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 14, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Intervention Participants will engage in 2-3 supervised high intensity aerobic and resistance exercise sessions per week.	Other: High Intensity Interval Training Participants will perform high-intensity aerobic and resistance exercise Other Names: HIIT
No Intervention: Control Participants will continue daily routine as usual and given an informational flyer on physical activity and cancer.

Arm

Intervention/Treatment

Experimental: Exercise Intervention

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

Other: High Intensity Interval Training

Participants will perform high-intensity aerobic and resistance exercise

Other Names:

HIIT

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Docetaxel chemotherapy tolerability [2 years]
Number of Changes or delays in docetaxel treatment schedule or dosing (tolerability)
Docetaxel chemotherapy toxicity [2 years]
Rates of CT CAE v.5 reported symptoms related to treatment
Functional assessment of Cancer therapy (FACT)-Taxane subscale [Baseline to 2 years]
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 [Baseline to 2 years]
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) [Baseline to 2 years]
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) [Baseline to 2 years]
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) [Baseline to 2 years]
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 [Baseline to 2 years]
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

Other Outcome Measures

Serum inflammatory biomarkers associated with tumor progression [2 years]
Compare changes in levels of serum measurements of biomarkers such as tumor necrosis factor alpha (pg/ml) and interleukins (pg/ml).
Body Composition [2 years]
Compare changes in fat free mass and fat mass measured with dual energy x-ray absorptiometry (DEXA) scan from baseline to end-of-study
Muscular Strength [2 years]
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.
Aerobic Fitness [2 years]
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.
Cognitive function changes over time [2 years]
Compare cognitive function changes between groups over time measured by Cambridge Neuropsychological Test Automated Battery (CANTAB).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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).