Clinical trial NCT05156372: Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients
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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Docetaxel chemotherapy tolerability
timeFrame: 2 years
measure: Docetaxel chemotherapy toxicity
timeFrame: 2 years
measure: Functional assessment of Cancer therapy (FACT)-Taxane subscale
timeFrame: Baseline to 2 years
Secondary outcomes:
measure: Functional assessment of Cancer therapy (FACT)-G
timeFrame: Baseline to 2 years
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Baseline to 2 years
measure: European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline to 2 years
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to 2 years
measure: Godin Leisure
timeFrame: Baseline to 2 years
Other outcomes:
measure: Serum inflammatory biomarkers associated with tumor progression
timeFrame: 2 years
measure: Body Composition
timeFrame: 2 years
measure: Muscular Strength
timeFrame: 2 years
measure: Aerobic Fitness
timeFrame: 2 years
measure: Cognitive function changes over time
timeFrame: 2 years
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Darpan I Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References: