Soy Bread Diet for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether eating soy bread can boost the immune system in men starting hormone therapy for prostate cancer. The study compares the effects of soy bread versus wheat bread over approximately 20 weeks. It aims to determine if soy's components can aid in preventing or managing prostate cancer. Men diagnosed with prostate cancer who are about to begin a new course of hormone therapy may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings in prostate cancer management.
Will I have to stop taking my current medications?
The trial requires you to stop taking all current vitamin and mineral supplements and any complementary or alternative products that target the prostate or affect hormones. You will need to take a standardized supplement provided by the study and avoid other dietary or alternative medications during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that soy bread, which contains soy isoflavones, might be safe for people with prostate cancer. Studies have found that men who consumed soy bread had lower levels of certain inflammation markers in their blood. This suggests that soy bread might support the immune system and could benefit those with prostate cancer.
Participants in previous studies who ate soy bread did not report any major safety issues, and no significant negative effects were linked to its consumption. This makes soy bread a promising and potentially safe option for prostate cancer patients to include in their diet.
While this trial is still in an early stage, mainly focusing on safety, other studies have shown that soy in food is generally well-tolerated. This offers reassurance about its safety for those considering joining the trial.12345Why do researchers think this study treatment might be promising for prostate cancer?
Unlike the standard treatments for prostate cancer, such as surgery, radiation, and hormone therapy, soy bread introduces a dietary approach that is both novel and non-invasive. This treatment leverages the potential cancer-fighting properties of soy, which contains compounds like isoflavones that may help inhibit cancer growth. Researchers are excited about soy bread because it offers a simple, daily dietary intervention that could complement existing therapies and potentially reduce reliance on more aggressive treatments.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
This trial will compare the effects of consuming soy bread versus wheat bread in men with prostate cancer who are beginning androgen deprivation therapy. Research has shown that eating soy bread, which participants in the soy bread intervention arm will consume, can help boost the immune system in men with prostate cancer. Studies have found that soy bread is linked to lower levels of certain proteins that can worsen cancer. This decrease in inflammation might help the body fight cancer more effectively. Additionally, eating soy foods like soy bread has been connected to a lower risk of developing prostate cancer. While there is still more to learn, these findings suggest that soy bread could be a helpful addition for those receiving hormone therapy for prostate cancer.12456
Who Is on the Research Team?
Steven Clinton, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Men with prostate cancer starting androgen deprivation therapy can join this trial. They must have normal organ function tests, agree to stop taking vitamins/minerals except those provided by the study, not be on steroids or other prostate-targeting supplements, and have no history of certain medical conditions like Crohn's disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume 2 slices of soy or wheat bread daily for approximately 20 weeks while undergoing androgen deprivation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Soy Bread
Trial Overview
The trial is testing if eating soy bread can boost immune function in men undergoing hormone therapy for prostate cancer compared to wheat bread. Participants will eat the assigned bread type while their immune response is monitored.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Men who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of soy bread daily for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits.
Men who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of wheat bread for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Consumption of soy isoflavone enriched bread in men with ...
Soy bread intervention is associated with decreased pro-inflammatory cytokines and chemokines in peripheral blood of prostate cancer patients.
NCT03654638 | Soy Bread Diet in Improving Immune ...
Components found in soy foods may influence the immune system in a way that may be beneficial for prostate cancer prevention and survivorship. Detailed ...
3.
aacrjournals.org
aacrjournals.org/cancerpreventionresearch/article/doi/10.1158/1940-6207.CAPR-14-0464/36723/am/Consumption-of-soy-isoflavone-enriched-bread-inConsumption of soy isoflavone enriched bread in men with ...
Consumption of soy isoflavone enriched bread in men with prostate cancer is associated with reduced pro-inflammatory cytokines and immunosuppressive cells.
Soy Bread Diet for Prostate Cancer · Info for Participants
Trial Overview The trial is testing if eating soy bread can boost immune function in men undergoing hormone therapy for prostate cancer compared to wheat bread.
Soy Consumption and the Risk of Prostate Cancer
We found that unfermented soy food products were associated with a decreased risk of PCa (p < 0.001), while fermented soy food products had no associations with ...
Soy consumption and prostate cancer risk in men
The results of this analysis suggest that consumption of soy foods is associated with a reduction in prostate cancer risk in men.
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