Resistance Training +/− Creatine for Prostate Cancer

Overseen By Susan Sharry

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: University of Utah

Must be taking: CYP17A1 inhibitors, GnRH agonists

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Low eGFR, Extensive bone disease, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how resistance training, with or without creatine supplements (a dietary supplement), might improve body composition and overall health in individuals with metastatic prostate cancer. The researchers aim to determine if these exercises can reduce fatigue and enhance physical function. Participants are divided into two groups: one performs resistance training with creatine, while the other engages in resistance training alone. Individuals with stable metastatic prostate cancer on their current therapy who are willing to exercise at home twice a week may be suitable candidates. As an Early Phase 1 trial, this research seeks to understand how these interventions work in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. However, you must be on a stable regimen of certain prostate cancer treatments for at least 12 weeks before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that creatine monohydrate is safe for people with prostate cancer. One study found no harmful side effects from creatine use in these patients. Another source states that taking 3 to 5 grams of creatine daily is generally safe for adults. However, individuals with kidney disease should consult a doctor first.

Regarding resistance training, studies indicate it is safe and beneficial for prostate cancer patients. Exercise may help reduce some side effects of cancer treatments and might even slow the cancer's progress. Overall, both creatine and resistance training are well-tolerated by prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, this approach focuses on resistance training with or without creatine supplementation. Researchers are excited because resistance training can improve muscle strength and overall physical health, potentially offering a non-invasive option to support patients during cancer treatment. Adding creatine, a popular supplement for enhancing muscle performance, might further boost these benefits, representing a promising, supportive strategy alongside conventional therapies.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that strength training can greatly benefit prostate cancer patients by reducing cancer severity, slowing tumor growth, and increasing muscle size and strength. These effects can enhance physical abilities and improve quality of life. In this trial, one group of participants will engage in resistance training alone, while another group will combine resistance training with creatine monohydrate supplementation.

Studies have produced mixed findings regarding creatine monohydrate. While it may aid muscle growth in some cancers, it does not appear to significantly enhance strength training benefits for prostate cancer specifically. Nonetheless, combining exercise with potential creatine support could still improve overall health outcomes. ^{1 2 3 5 6}

Who Is on the Research Team?

Adriana Coletta

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

This trial is for metastatic prostate cancer patients who can read English, have internet access for video calls, and are willing to do a home-based exercise program. They must be on certain cancer treatments for at least 12 weeks before joining and get their oncologist's okay to start exercising.

Inclusion Criteria

I am willing to not take any creatine supplements if I join the resistance training group.

I am willing to take creatine and do resistance training without using other supplements for 12 weeks.

I've been on hormone therapy for prostate cancer for at least 12 weeks.

Exclusion Criteria

I haven't had chemotherapy in the last 12 weeks.

My doctor thinks my cancer spread won't stop me from joining the exercise program.

My kidney function is severely reduced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo resistance training with or without creatine supplementation for 12 weeks

12 weeks

24 visits (in-person, twice weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Creatine Monohydrate
• Exercise Intervention

Trial Overview The study looks at whether resistance training improves body composition and health in prostate cancer patients with fatigue. It compares the effects of doing exercises alone or combined with a creatine supplement over 12 weeks.

How Is the Trial Designed?

Group I: Group II (resistance training, creatine supplementation) Experimental Treatment 3 Interventions

Patients complete POWER resistance training program sessions twice weekly over 30-60 minutes each for 12 weeks and receive creatine monohydrate supplementation given orally 4 times daily during week 1, and then QD (once per day) during weeks 2-12.

Group II: Group I (resistance training) Experimental Treatment 2 Interventions

Patients complete POWER resistance training program sessions twice weekly over 30-60 minute each for 12 weeks.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

This study aims to evaluate the safety and efficacy of a 3-month modular multi-modal exercise program for 90 prostate cancer survivors with bone metastases, addressing concerns about muscle atrophy and functional impairments due to prior treatments.

The exercise program is designed to be safe for patients with bone metastases, potentially improving physical function and delaying skeletal complications, which could significantly enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. Galvão, DA., Taaffe, DR., Cormie, P., et al.[2022]

Supervised physical training significantly improves muscle strength in prostate cancer patients undergoing androgen deprivation therapy (ADT), with notable increases in chest strength (3.15 kg) and leg press strength (27.46 kg).

However, the training did not lead to significant changes in lean body mass, suggesting that while exercise can enhance strength, it may not be enough to counteract muscle loss associated with ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Physical Training Enhances Muscle Strength but Not Muscle Mass in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: A Systematic Review and Meta-Analysis. Chen, Z., Zhang, Y., Lu, C., et al.[2020]

This phase III randomized controlled trial involves 866 participants with metastatic castrate-resistant prostate cancer (mCRPC) to assess whether supervised high-intensity aerobic and resistance exercise can improve overall survival compared to self-directed exercise.

The study will also explore the relationship between exercise and various health factors, such as immune function and metabolic biomarkers, which may help understand how exercise impacts survival outcomes in mCRPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. Newton, RU., Kenfield, SA., Hart, NH., et al.[2022]

This study aims to evaluate the effectiveness of a 16-week supervised resistance training program, with and without creatine supplementation, in patients with breast cancer, focusing on improving muscle strength and preventing sarcopenia.

Participants will be randomly assigned to either a resistance training group or a resistance training plus creatine group, allowing researchers to assess the specific impact of creatine on strength adaptations in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study): Protocol for a Randomized Controlled Trial. Martinez Aguirre-Betolaza, A., Cacicedo, J., Castañeda-Babarro, A.[2023]

A 12-week resistance training program significantly improved lean mass, reduced body fat percentage, and enhanced strength and quality of life in prostate cancer patients undergoing androgen deprivation therapy, with notable improvements in sarcopenia prevalence.

The addition of protein supplementation did not provide extra benefits for body composition changes compared to resistance training alone, and the intervention did not significantly affect metabolic syndrome or physical function outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. Dawson, JK., Dorff, TB., Todd Schroeder, E., et al.[2018]

Resistance exercise (RE) is shown to be a safe and effective method to improve muscular strength, performance, fatigue, and quality of life in prostate cancer patients undergoing androgen deprivation therapy, based on a systematic review of studies published until September 2014.

While RE has clear benefits for physical performance and quality of life, the evidence regarding its effects on cardiovascular performance, body composition, and other health markers remains inconclusive, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on physical performance and health-related quality of life in prostate cancer patients: a systematic review. Hasenoehrl, T., Keilani, M., Sedghi Komanadj, T., et al.[2022]

Resistance exercise (RE) significantly improves body composition and physical function in prostate cancer patients, with notable increases in lean body mass and appendicular skeletal mass, as well as enhanced leg press strength and stair climbing ability.

Starting RE immediately after androgen deprivation therapy (ADT) and maintaining the exercise for at least 6 months leads to greater improvements, especially when performed at an intensity of 8-12 repetitions maximum (RM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy: an update systematic review and meta-analysis. Tian, S., Ding, M., Sun, H.[2022]

In a study of 83 prostate cancer patients undergoing 6 months of resistance exercise, high compliance (88.5%) was linked to greater improvements in trunk fat mass and appendicular lean mass, indicating that sticking to the exercise regimen can enhance body composition outcomes.

Despite varying levels of compliance, significant improvements in physical function and muscle strength were observed across the board, suggesting that resistance exercise is beneficial for all participants, even those with lower attendance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting Attendance and Resistance Exercise Compliance in Men with Localized Prostate Cancer. Lopez, P., Taaffe, DR., Newton, RU., et al.[2023]

This study is a randomized, double-blind, placebo-controlled trial investigating the effects of creatine supplementation combined with resistance training on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy, with a focus on fat-free mass as the primary endpoint.

If successful, the trial could show that creatine supplementation enhances the benefits of resistance training, potentially improving body composition and quality of life for cancer patients, which would be significant for future treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial. Fairman, CM., Kendall, KL., Newton, RU., et al.[2020]

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

Citations

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2. sciencedirect.com sciencedirect.com/science/article/pii/S1440244024005152

Creatine supplementation does not add to resistance ... Creatine supplementation does not add to resistance training effects in prostate cancer patients under androgen deprivation therapy: A double-blind randomized ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-09483

Creatine Supplementation in Combination with Resistance ... Treatment of metastatic prostate cancer can cause significant loss of muscle mass, which can lead to reduced survival and quality of life. Creatine helps supply ...

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The association between dietary creatine intake and ... These findings suggest that higher dietary creatine intake may reduce cancer risk in a nationally representative adult population.

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Cyclocreatine Suppresses Creatine Metabolism and Impairs ... Enhanced creatine uptake drives prostate cancer progression and confers a metabolic vulnerability to treatment with the creatine analog ...

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What is creatine? Potential benefits and risks of this ... Otherwise, an adult dose of 3 to 5 grams of creatine daily is safe. However, people with kidney disease should consult with their doctor prior ...