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

20 Participants Needed

Trial Summary

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 data supports the idea that Diet and Physical Activity for Prostate Cancer is an effective treatment?

The available research shows that diet and physical activity can improve the quality of life and survival for men with prostate cancer. A systematic review found that diet interventions, either alone or combined with exercise, led to significant weight loss in men treated for prostate cancer, with weight loss ranging from 0.8 kg to 6.1 kg. While exercise alone did not result in weight loss, it was aimed at improving fitness and quality of life. This suggests that diet and exercise together can be an effective treatment for managing prostate cancer. ^{1 2 3 4 5}

What safety data exists for diet and physical activity interventions in prostate cancer treatment?

The safety data for diet and physical activity interventions in prostate cancer treatment is supported by several studies. These interventions, including exercise and dietary changes, have been shown to improve quality of life, body composition, and physical performance in men with prostate cancer. Specifically, they can mitigate adverse effects of androgen deprivation therapy, such as sarcopenic obesity and osteoporosis, and improve cardiovascular and muscular endurance. The interventions are generally well-tolerated and feasible, as demonstrated in various trials and studies. ^{1 2 4 6 7}

Is diet and physical activity a promising treatment for prostate cancer?

Yes, diet and physical activity are promising treatments for prostate cancer. They are linked to better quality of life and may help reduce the chances of the cancer coming back. ^{1 2 3 4 8}

What is the purpose of this trial?

This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). ADT effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of RT. Despite the clinical gains, ADT leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. A diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving ADT and RT.

Research Team

Marian L. Neuhouser

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Canada 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. [2021]

2. United States 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). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on body composition in prostate cancer patients on androgen deprivation therapy. [2022]

7. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

8. Netherlands 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. [2022]