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Prostate Cancer MetastaticHIIT PCaNCT05156372

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

A study testing High Intensity Interval Training in people with Prostate Cancer Metastatic and Castrate Resistant Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
High Intensity Interval Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2023to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT Health San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
High Intensity Interval Training
Keywords
metastatic prostate cancer, high-intensity interval training, HIIT, exercise, exercise oncology, resistance training
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval TrainingOther

    Also called HIIT

    Participants will perform high-intensity aerobic and resistance exercise

Study groups in NCT05156372
Study groupRoleWhat they receive
Exercise InterventionExperimentalParticipants will engage in 2-3 supervised high intensity aerobic and resistance exercise sessions per week.
Receives: Other: High Intensity Interval Training
ControlNo interventionParticipants will continue daily routine as usual and given an informational flyer on physical activity and cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Docetaxel chemotherapy tolerability

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

    Measured: 2 years

  2. Docetaxel chemotherapy toxicity

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

    Measured: 2 years

  3. 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.

    Measured: Baseline to 2 years

Secondary outcomes (5)

  1. 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.

    Measured: Baseline to 2 years

  2. 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.

    Measured: Baseline to 2 years

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

    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).

    Measured: Baseline to 2 years

  4. 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.

    Measured: Baseline to 2 years

  5. 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

    Measured: Baseline to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study startDec 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: PI left the institution, no subjects were enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156372
Sponsor's protocol ID
CTMS 21-0078
Other IDs
HSC20210663H
Acronym
HIIT PCa
Status last verified
Feb 2024
First submitted
29 Sep 2021
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training in people with Prostate Cancer Metastatic and Castrate Resistant Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Docetaxel chemotherapy tolerability (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.

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