Genistein for Urinary Bladder Cancer

1
Effectiveness
2
Safety
Emory University Hospital Midtown, Atlanta, GA
Urinary Bladder Cancer+1 More
Genistein - Drug
Eligibility
18+
All Sexes
Eligible conditions
Urinary Bladder Cancer

Study Summary

This study is evaluating whether a chemical found in soy beans may help with lower urinary tract symptoms in patients with bladder cancer.

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Eligible Conditions

  • Urinary Bladder Cancer
  • Urinary Bladder Neoplasms
  • Bladder Cancer, Cancer

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Genistein will improve 1 primary outcome and 1 secondary outcome in patients with Urinary Bladder Cancer. Measurement will happen over the course of At 10 weeks of treatment..

Week 10
Rate of cancer recurrence determined at 10-week biopsy.
Week 6
Change in severity of urinary symptoms as determined by the IPSS questionnaire score.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Sugar pill
Genistein supplement
Placebo group

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Genistein is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Genistein supplement
Drug
30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks.
Sugar pill
Drug
Patients will be given placebo pills for 10 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Genistein
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 6 weeks of treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 6 weeks of treatment for reporting.

Who is running the study

Principal Investigator
O. K.
Prof. Omer Kucuk, Professor
Emory University

Closest Location

Emory University Hospital Midtown - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is generally straightforward The diagnosis of superficial bladder cancer is typically straightforward. show original
I am willing and able to give a blood sample. show original
Male or female gender
You must be 18 years or older to use this service show original
The person is willing and able to fill out a pill diary to ensure compliance. show original
The person is willing and able to sign an informed consent form. show original
This study does not require birth control. show original
for bladder cancer Scheduled for a BCG intravesical therapy for bladder cancer. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for urinary bladder cancer?

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Urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) is treated with a variety of treatments--such as surgery (cystectomy), radiotherapy, chemotherapy, and immunotherapy. The optimal treatment for which patients are treated depends on age, gender, performance status, cancer location, and other factors. Patients are usually treated with multimodal treatment, as that is more effective in patients with poorer prognosis tumours.

Unverified Answer

What are the signs of urinary bladder cancer?

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Most urologists are familiar with signs and symptoms of bladder cancer, but many of these signs are nonspecific. Common signs include blood in the urine, hematuria, and urgency. Hematuria in men is especially worrisome.

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How many people get urinary bladder cancer a year in the United States?

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At least 20,000 people a year in the United States will be diagnosed with bladder cancer. The absolute risk in the United States is low, but mortality is high.

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What causes urinary bladder cancer?

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A majority of non-invasive urinary bladder cancers are associated with benign papillary lesions or cystitis, and the bladder cancer is most probably a multifocal malignancy. Lymph node and renal involvement has been reported for the first time; most of this is due to spread along the renal vein to adjacent vessels.

Unverified Answer

Can urinary bladder cancer be cured?

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This analysis suggests that urinary bladder cancer can be curable using a multimodality treatment approach. In this experience, nearly 30% of men with bladder cancer and clinically organ confined or organ invasiveness disease have been able to achieve curative treatment.

Unverified Answer

What is urinary bladder cancer?

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UBC, also called bladder cancer, is a malignancy that originates from cells inside the urinary bladder that are able to spread to other organs such as lymph nodes, liver or bones. The 5 year survival rate in the UK is around 95% although this was reduced to 81% in the USA. Urinary bladder cancer is more common in males than females with about 60% of patients being male. The risk of developing bladder cancer increases with age. The incidence rate is greater in Asians than those of other ethnicities.

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Have there been any new discoveries for treating urinary bladder cancer?

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There have been some important new findings for treating urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) patients in the past 20 years. One of which is cryoablation for tumors of T1a - T2a and T3a-4a stages and other forms were in the forefront of surgery research. More than half the patients with T1b cancer were also subjected to cryoablation. Patients with higher stages of T1b - T2a cancer had less chances of survival without cryoablation. We also found that T1b - T2a and T3a cancer patients undergoing cryoablation had better quality of life (QOL) compared to other urinary tract cancer patients.

Unverified Answer

What is the survival rate for urinary bladder cancer?

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The median survival rate of urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) was 34months. The major cause of death in urinary bladder cancer was distant metastasis. Age at cancer onset was positively correlated with poorer survival rates. For patients in the age group younger than 30 years, the survival rates were poorer than for the other age groups; for older patients, the survival rates were equal to or better than other age groups. In patients 50 years old or older, the survival rates were equal to or better than other age groups except in cases of bladder cancer that spread to both the pelvis and peritoneum.

Unverified Answer

Have there been other clinical trials involving genistein?

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The majority of the studies evaluated by this review, published between 1975 and 2002, reported that genistein has some effect but the most common outcome metric found to have a statistically significant improvement was related to improved quality of life. However, none of these studies involved the rigorous methodologies associated with a clinical trial with a placebo group, which is needed to support any conclusions about genistein in urological cancer.

Unverified Answer

What does genistein usually treat?

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Genistein seems to have little clinical effect in uncomplicated UT B/B patients, except in patients with concomitantly high levels of free or unbound estradiol in the circulation. Clinically, genistein may provide no additional benefit for patients with low E2 levels with or without concomitantly elevated unbound E2 levels. However, genistein has a positive impact on the free fraction of E2, thus increasing the relative effect of E2 on the maturation of bladder cancer.

Unverified Answer

What is the latest research for urinary bladder cancer?

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UBC treatment is still not the gold standard for urothelial carcinoma and other forms of urothelium-forming cancers. Furthermore, many cases with urothelial carcinoma of the bladder are already diagnosed on biopsies when still in situ. Hence, more studies involving patients from low incidence populations as well as more studies involving tissue analysis in general are needed for UBC diagnosis and more research on the pathogenesis.

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Who should consider clinical trials for urinary bladder cancer?

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Patients with a history of previous pelvic radiotherapy or a history of malignant disease should consider clinical trials before starting therapy. Although patients should be advised to discuss a potential therapeutic trial with a urologist before initiating therapy, the impact of the tumor's biological characteristics may outweigh that of the patient's cancer history and treatment choices. [Power(http://www.withpower.com/clinical-trials/cancer-of-the-bladder/who-should-consider-clinical-trials/).

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Get access to this novel treatment for Urinary Bladder Cancer by sharing your contact details with the study coordinator.