Diet and Physical Activity for Prostate Cancer

Overseen By Marian L. Neuhouser

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Research Center

Must be taking: LHRH therapies

Disqualifiers: Metastatic disease, T2D, CVD, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how diet and physical activity influence blood measures related to insulin resistance and cholesterol in men with prostate cancer undergoing radiation and hormone therapy. While hormone therapy can slow cancer growth, it also causes side effects like weight gain and muscle loss. Participants will be divided into two groups: one will receive personalized diet and exercise plans, and the other will receive standard lifestyle advice. This trial may suit individuals with prostate cancer who can exercise and are not currently in a structured diet or fitness program. As an unphased trial, this study offers a unique opportunity to contribute to understanding lifestyle impacts on cancer treatment outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does require that you are on androgen deprivation therapy (ADT) as part of the treatment.

What prior data suggests that this diet and physical activity intervention is safe for prostate cancer patients?

Research has shown that dietary changes, such as those used in treating prostate cancer, are generally manageable for most people. One study found that a low-fat diet positively impacted prostate cancer cells without major safety concerns. Additionally, a review indicated that plant-based diets might reduce the risk of cancer progression, suggesting their safety for long-term use.

Exercise programs are also safe for prostate cancer patients. Studies have demonstrated that both aerobic (cardio) and resistance (strength) exercises can alleviate treatment side effects, such as those from hormone therapy, without causing harm. Exercise is associated with improved quality of life and better overall health, with no major negative effects reported.

Overall, both dietary and exercise changes have strong safety records and are considered safe and beneficial for individuals with prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for prostate cancer because it explores how lifestyle changes can impact the disease, which is a fresh approach compared to standard treatments like surgery, radiation, or hormone therapy. The trial's focus on diet and physical activity aims to empower patients with non-invasive tools, like personalized diet plans and exercise regimens, to potentially improve their quality of life and overall health. This approach is distinctive as it looks at how modifying daily habits could complement traditional treatments, offering a holistic strategy that may enhance patient well-being and long-term outcomes.

What evidence suggests that this diet and physical activity intervention is effective for prostate cancer patients undergoing ADT and RT?

Research has shown that dietary changes can affect prostate cancer outcomes. One study found that a low-fat diet can slow the growth of prostate cancer cells. Another review indicated that dietary changes can improve heart and metabolic health in prostate cancer patients.

Exercise also offers benefits. Studies have demonstrated that exercise can enhance quality of life and mental clarity in men with prostate cancer. Both aerobic and strength exercises can boost overall health and well-being, including sexual health and mood.

This trial will compare two approaches: Group I participants will receive a comprehensive program involving both diet and physical activity interventions, while Group II participants will receive standard lifestyle recommendations. These findings suggest that combining diet and exercise can help reduce some side effects of prostate cancer treatments, such as those from androgen deprivation therapy. ^{2 3 6 7 8}

Who Is on the Research Team?

Marian L. Neuhouser

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

Men aged 40-70 with prostate cancer set to receive radiation and hormone therapy can join. They must have a specific type of prostate cancer (adenocarcinoma), be physically able to exercise, and not already planning to start a diet or fitness program. Men with severe diabetes, recent heart attacks or strokes, cognitive issues, substance abuse problems, or advanced cancer cannot participate.

Inclusion Criteria

I am between 40 and 70 years old.

I am receiving hormone therapy and radiation for my cancer.

My prostate cancer is confirmed and considered intermediate or high risk.

Exclusion Criteria

You have poorly controlled Type 2 Diabetes (HbA1c of 10 or higher in the past year) or have had a heart attack or stroke in the last six months.

My cancer has spread to other parts of my body.

You cannot be currently enrolled in a commercial or structured diet or fitness program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diet and physical activity intervention or standard lifestyle recommendations over 6 months

6 months

10 in-person or virtual sessions with a dietitian, 2 sessions with an exercise psychologist, up to 21 additional supervised exercise sessions

Follow-up

Participants are monitored for changes in lean mass, fat mass, insulin resistance, body weight, and waist circumference

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Best Practice
• Dietary Intervention
• Exercise Intervention
• Quality-of-Life Assessment
• Questionnaire Administration

Trial Overview The trial is testing if changing diet and increasing physical activity can prevent negative changes in metabolism caused by hormone therapy for prostate cancer. It looks at how these lifestyle changes affect blood lipids, insulin resistance, body composition, muscle health, and overall quality of life during treatment.

How Is the Trial Designed?

Group I: Group I (diet, physical activity) Experimental Treatment 4 Interventions

Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.

Group II: Group II (standard lifestyle recommendations) Active Control 3 Interventions

Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The study demonstrated that a web-based behavioral intervention for men with prostate cancer is feasible and acceptable, with a high follow-up rate of 82.7% at 3 months and 77.2% at 6 months among 202 participants.

Participants who received the most comprehensive intervention (level 4) showed small improvements in diet and physical activity compared to those in the least intensive group (level 1), indicating that more tailored support may enhance health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. Chan, JM., Van Blarigan, EL., Langlais, CS., et al.[2021]

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]

Only a small percentage of long-term prostate cancer survivors (11.8% using diet and 7.8% using exercise) actively employed dietary changes or exercise to manage their condition, indicating a potential gap in awareness or utilization of these strategies.

Younger, more educated survivors, and those involved in support groups were more likely to adopt these lifestyle changes, suggesting that targeted counseling could enhance the use of diet and exercise to improve quality of life and cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. Hughes, S., Egger, S., Carle, C., et al.[2020]

A systematic review of 20 randomized controlled trials found that diet interventions, either alone or combined with exercise, can lead to significant weight loss in men treated for prostate cancer, with weight loss ranging from 0.8 kg to 6.1 kg.

Exercise alone did not result in weight loss, as most trials focused on improving fitness and quality of life rather than reducing body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. Mohamad, H., McNeill, G., Haseen, F., et al.[2022]

A systematic review of 13 randomized control trials involving 1057 prostate cancer patients found that supervised exercise interventions significantly reduced fatigue symptoms and improved quality of life, with benefits lasting up to 6 months.

While exercise improved fatigue and quality of life as measured by specific scales, it did not show significant effects on depression or anxiety levels in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Exercise on Fatigue, Quality of Life, and Psychological Function for Men with Prostate Cancer: Systematic Review and Meta-analyses. Vashistha, V., Singh, B., Kaur, S., et al.[2022]

The EX+D (exercise and dietary) intervention significantly improved body composition in prostate cancer patients undergoing androgen deprivation therapy, showing reductions in fat mass and increases in lean mass compared to standard care.

Improvements in body composition from the EX+D intervention were associated with better mobility performance and strength, highlighting its potential benefits for physical function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy. Chaplow, ZL., Focht, BC., Lucas, AR., et al.[2022]

The Prostate 8-II trial is a 4-arm randomized controlled trial involving 200 men with prostate cancer, aiming to assess the effects of exercise and diet interventions on cancer recurrence and patient quality of life over a 24-month period after radical prostatectomy.

Participants are assigned to one of four groups (exercise-only, diet-only, exercise + diet, or usual care) and will receive various resources and support to help achieve their health goals, with the primary focus on measuring biochemical recurrence and secondary outcomes related to tumor biomarkers and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II). Van Blarigan, EL., Chan, JM., Sanchez, A., et al.[2023]

A study of 40 Italian men newly diagnosed with prostate cancer revealed that while 65% reported being physically active, over half did not meet recommended exercise levels, indicating a need for improved physical activity among this group.

Despite many participants being aware of their unhealthy habits, such as high alcohol consumption and being overweight, most were unwilling to change their lifestyle, highlighting the importance of healthcare professionals to encourage motivation for healthier behaviors during this critical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. Bressi, B., Iotti, C., Cagliari, M., et al.[2022]

Citations

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Nutrition, dietary interventions and prostate cancer Growth inhibitory effect of low fat diet on prostate cancer cells: results of a prospective, randomized dietary intervention trial in men with prostate cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000355

Review article The effect of dietary interventions or patterns ... This review synthesizes the evidence on the effect of dietary interventions on cardiometabolic biomarkers and cardiovascular disease risk in prostate cancer ...

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Dietary interventions in cancer: a systematic review of all ... In this systematic review, we assessed all randomized controlled trials (RCTs) investigating dietary interventions for cancer patients.

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a target trial emulation in the Health Professionals Follow-up ... We emulated a target trial of recommendation-based physical activity and dietary strategies and 26-year risks of prostate cancer, adjusting for risk factors ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2758598

Effect of a Behavioral Intervention to Increase Vegetable ... A behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression among men with early-stage ...

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Dietary Patterns in Prostate Cancer Prevention and ... Our review suggests that plant-based and healthy dietary patterns are associated with lower PC risks that are more obvious for progression than ...

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A Systematic Review of Dietary, Nutritional, and Physical ... Results: Forty-four randomized controlled trials of lifestyle interventions, with prostate cancer progression or mortality outcomes, were identified.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04985565

Neoadjuvant Dietary Intervention in Intermediate Risk ... This clinical trial studies the effects of a dietary intervention prior to surgery (neoadjuvant) in patients with intermediate risk prostate cancer.