Exercise for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Christina Dieli-Conwright, PhD, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Metastasis, Other active malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether a 16-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among Black men with prostate cancer undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment for prostate cancer?

Research shows that high-intensity interval training (HIIT) can improve physical function, quality of life, and reduce fatigue in prostate cancer patients. It may also enhance the immune response by increasing natural killer cell activity, which is important for fighting cancer. ^{1 2 3 4 5}

Is high-intensity interval training (HIIT) generally safe for humans?

HIIT is generally well-tolerated and may offer health benefits, but there are some risks, such as thromboembolic events (blood clots) in certain populations, like those undergoing chemotherapy for testicular cancer. More research is needed to confirm safety across different groups. ^{1 2 3 6 7}

How is high-intensity interval training (HIIT) unique as a treatment for prostate cancer?

High-intensity interval training (HIIT) is unique for prostate cancer treatment because it can increase natural killer (NK) cell infiltration in tumors, which may help the body fight cancer cells. Unlike traditional treatments, HIIT focuses on short bursts of intense exercise, which can improve motivation and physical function in patients, especially those undergoing active surveillance or androgen deprivation therapy. ^{1 2 3 8 9}

Research Team

Christina Dieli-Conwright, PhD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for Black men over 18 with early-stage prostate cancer who are on active surveillance. They should be able to visit Dana-Farber Cancer Institute, understand English, sign consent forms, and have medical clearance to exercise. They must do less than 60 minutes of moderate-to-vigorous exercise weekly and not plan any invasive treatments for the next 16 weeks.

Inclusion Criteria

I am currently being closely monitored for my condition without active treatment.

I do not plan to undergo invasive prostate cancer treatment within the next 16 weeks.

I have been diagnosed with early-stage prostate cancer.

Exclusion Criteria

I have cancer that has spread or I am being treated for another cancer.

Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise

I am currently undergoing treatment aimed at curing my prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a 16-week, home-based, virtually supervised exercise program or usual care

16 weeks

Virtual training sessions three times weekly for Group A; Testing visits at Week 1, 9, and 19 for Group A; Testing visits at Week 1 and 18 for Group B

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

Open-label extension (optional)

Participants in Group B may opt into a 16-week HIIT exercise program after the main trial

16 weeks

Treatment Details

Interventions

• High-Intensity Interval Training Exercise Program

Trial Overview The REMOVE Trial tests if a home-based, virtual high-intensity interval training (HIIT) program can slow prostate cancer progression in participants. It's a supervised 16-week aerobic exercise regimen designed specifically for this study.

Participant Groups

Group I: Group B: 16-Week Usual Care Experimental Treatment 1 Intervention

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows: * Testing visits at Week 1 and 18 for physical exams, physical fitness and function assessments, and survey questionnaires. * Upon completion of post-intervention assessments, participants will have the option to take part in the 16-week HIIT exercise program.

Group II: Group A: 16-Week HIIT Exercise Program Experimental Treatment 1 Intervention

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows: * Testing visits at Week 1, 9, and 19 for physical exams, physical fitness and function assessments, survey questionnaires, and cardiopulmonary fitness assessment. * Virtual, aerobic training sessions three times weekly with trained oncology exercise specialist.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Findings from Research

In a study involving 52 men with prostate cancer on active surveillance, those participating in a 12-week supervised high-intensity interval training (HIIT) program showed excellent adherence, attending 96% of sessions and reporting increased enjoyment and motivation for exercise after the program.

The HIIT group not only felt more in control and confident about their exercise plans compared to the usual care group, but they also faced minimal barriers to participation, indicating that HIIT could be a highly effective and motivating exercise option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supervised high-intensity interval training on motivational outcomes in men with prostate cancer undergoing active surveillance: results from a randomized controlled trial. Kang, DW., Boulé, NG., Field, CJ., et al.[2022]

In a study of 30 men with localized prostate cancer, preoperative high-intensity interval training (HIIT) did not show a significant difference in tumor natural killer (NK)-cell infiltration compared to usual care, suggesting that HIIT alone may not enhance this immune response.

However, within the group that participated in HIIT, there was a significant increase in NK-cell infiltration when analyzed per protocol, indicating that more consistent exercise sessions may positively influence immune cell activity in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. Djurhuus, SS., Simonsen, C., Toft, BG., et al.[2023]

A 12-week exercise program significantly improved physical function and health quality of life in 17 prostate cancer patients undergoing androgen deprivation therapy, with benefits lasting for 3-6 months post-program.

High-intensity interval training (HIIT) was more effective than moderate-intensity continuous training (MICT) for enhancing muscle endurance, which is crucial for preventing falls and fractures in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Physical Function and Quality of Life in Prostate Cancer Patients Receiving Androgen Deprivation Therapy: High-Intensity Interval Training versus Moderate-Intensity Continuous Training. Yoo, S., Lee, KH., Jamrasi, P., et al.[2023]

In a study of 72 prostate cancer patients undergoing radiation therapy, both high-intensity interval training (HIIT) and resistance training (RES) significantly reduced cancer-treatment-related fatigue compared to usual care, indicating their efficacy in managing side effects of treatment.

Both exercise modalities were found to be safe, with no adverse events reported, and they improved functional exercise capacity, demonstrating that structured exercise can be beneficial during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Piraux, E., Caty, G., Renard, L., et al.[2021]

High-intensity interval training (HIIT) significantly improves aerobic capacity and reduces fatigue in prostate cancer patients, as shown in a meta-analysis of 6 studies involving 215 male participants with an average age of 64.4 years.

HIIT also effectively decreases PSA levels in prostate cancer patients, indicating potential benefits for disease management, although it does not significantly impact inflammatory markers like IL-6 or TNF-α.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-intensity interval training on aerobic capacity and fatigue among patients with prostate cancer: a meta-analysis. Chang, M., Wang, J., Hashim, HA., et al.[2022]

In a study of 40 men undergoing chemotherapy for testicular cancer, only one participant experienced a thromboembolic event during a 6-week high-intensity interval training (HIIT) program, suggesting that HIIT may not significantly increase the risk of such events in this population.

The HIIT program led to significant improvements in upper and lower body strength, indicating that it can be a feasible exercise option for men with testicular cancer undergoing chemotherapy, although no significant changes in cardiorespiratory fitness were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training and thromboembolic events during chemotherapy for testicular cancer: a retrospective analysis from the Body & Cancer cohort. Bloomquist, K., Andersen, C., Munck, S., et al.[2023]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

High-intensity interval training (HIIT) and resistance training (RT) are feasible and can improve muscle strength in men with prostate cancer on active surveillance, with HIIT increasing leg press strength and RT enhancing multiple strength measures.

RT specifically increased serum insulin-like binding protein-3 (IGFBP-3), which may help suppress tumor-promoting effects of insulin-like growth factor-I (IGF-I), suggesting a potential mechanism for its benefits in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial. Papadopoulos, E., Gillen, J., Moore, D., et al.[2022]

Whole-body electromyostimulation (WB-EMS) has been shown to significantly inhibit the growth and increase the death of prostate and colon cancer cells, based on serum analysis from advanced cancer patients who underwent a 12-week exercise program.

The study identified exercise-sensitive genes in prostate cancer cells that may play a role in how exercise affects cancer cell growth and apoptosis, highlighting the potential of incorporating exercise into cancer treatment plans, especially for patients who are physically weakened.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and advanced cancer: evidence of exercise-sensitive genes regulating prostate cancer cell proliferation and apoptosis. Schwappacher, R., Schink, K., Sologub, S., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of supervised high-intensity interval training on motivational outcomes in men with prostate cancer undergoing active surveillance: results from a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Physical Function and Quality of Life in Prostate Cancer Patients Receiving Androgen Deprivation Therapy: High-Intensity Interval Training versus Moderate-Intensity Continuous Training. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training compared with resistance training in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effect of high-intensity interval training on aerobic capacity and fatigue among patients with prostate cancer: a meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

High-intensity interval training and thromboembolic events during chemotherapy for testicular cancer: a retrospective analysis from the Body & Cancer cohort. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

High-intensity interval training or resistance training versus usual care in men with prostate cancer on active surveillance: a 3-arm feasibility randomized controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Physical activity and advanced cancer: evidence of exercise-sensitive genes regulating prostate cancer cell proliferation and apoptosis. [2021]