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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Participants will perform high-intensity aerobic and resistance exercise
UT Health San Antonio
San Antonio, Texas, United States
Docetaxel chemotherapy tolerability
Number of Changes or delays in docetaxel treatment schedule or dosing (tolerability)
Time frame: 2 years
Docetaxel chemotherapy toxicity
Rates of CT CAE v.5 reported symptoms related to treatment
Time frame: 2 years
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 1. =A little bit 2. =Somewhat 3. =Quite a bit 4. =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
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 1. =A little bit 2. =Somewhat 3. =Quite a bit 4. =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
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.
Time frame: Baseline to 2 years
European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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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
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.
Time frame: Baseline to 2 years
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
Time frame: Baseline to 2 years