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

NCT ID: NCT05156372

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

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.

Conditions

Prostate Cancer Metastatic; Castrate Resistant Prostate Cancer; Metastatic Prostate Cancer; Metastatic Prostate Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Intervention

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

Group Type: EXPERIMENTAL

High Intensity Interval Training

Intervention Type: OTHER

Participants will perform high-intensity aerobic and resistance exercise

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High Intensity Interval Training

Participants will perform high-intensity aerobic and resistance exercise

Intervention Type: OTHER

Other Intervention Names

HIIT

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darpan I Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

UT Health San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20210663H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS 21-0078

Identifier Type: -

Identifier Source: org_study_id