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

NCT05156372 | Withdrawn DMC

• 2 other identifiers: CTMS 21-0078HSC20210663H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Docetaxel chemotherapy tolerability

  Number of Changes or delays in docetaxel treatment schedule or dosing (tolerability)

  2 years

• Docetaxel chemotherapy toxicity

  Rates of CT CAE v.5 reported symptoms related to treatment

  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.

  Baseline to 2 years

Secondary Outcomes (5)

• Functional assessment of Cancer therapy (FACT)-G

  Baseline to 2 years

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  Baseline to 2 years

• European Organization for Research Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  Baseline to 2 years

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline to 2 years

• Godin Leisure

  Baseline to 2 years

Other Outcomes (5)

• Serum inflammatory biomarkers associated with tumor progression

  2 years

• Body Composition

  2 years

• Muscular Strength

  2 years

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Other: High Intensity Interval Training

Control

NO INTERVENTION

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

Interventions

High Intensity Interval Training OTHER

Participants will perform high-intensity aerobic and resistance exercise

Also known as: HIIT

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Darpan I Patel, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessments and analysis will be done by study staff blinded to the participant allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: December 14, 2021
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)