Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

broccoli sprout extract

complementary or alternative medicine procedure

Julie Brahmer, MD

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of broccoli sprout extract may prevent lung cancer.

PURPOSE: This clinical trial is studying how well broccoli sprout extract works in preventing lung cancer in smokers.

OBJECTIVES:

Primary

* Evaluate the effect of broccoli sprout extract on levels of DNA adducts in participants who smoke.
* Determine the effectiveness of broccoli sprout extract in reducing tobacco-carcinogen induced DNA adducts in these participants.

Secondary

* Determine the effects of broccoli sprout extract on markers of the Nrf2 pathway in these participants.
* Determine the effectiveness of broccoli sprout extract, in increasing the activity of the Nrf2 pathway, in these participants.
* Evaluate the feasibility of using lymphocytes and buccal cells to monitor DNA adducts and changes in the Nrf2 pathway in these participants.

OUTLINE: Participants are stratified according to GST genotypic polymorphism (M1 vs T1).

Participants receive oral broccoli sprout extract daily for 3 weeks. Participants keep a daily diary of their eating and smoking habits for 3 weeks before, during, and for 3 weeks after study treatment. They must continue to smoke during the study, but are encouraged to quit after completing the study treatment.

PROJECTED ACCRUAL: A total of 70 participants will be accrued for this study.

Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers

National Cancer Institute (NCI)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Herbal and Botanical

All Drugs and Chemicals

Mango

Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis

Mango Juice

James Marshall, PhD

Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.

Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.

Primary Objectives:

I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200 micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo definitive bladder resection for bladder cancer.

Secondary Objectives:

I. Establish the safety of administration of the broccoli extract on the bladder surgery specifically.

II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.

III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.

IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per dose per day of broccoli sprout extract in future therapeutic and prevention clinical trials.

Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks.

Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery

Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer

Number of participants with an adverse event.

Johns Hopkins University

Roswell Park Cancer Institute

Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.

broccoli sprout extract: Given orally

laboratory biomarker analysis: Correlative studies

Arm I

Patients receive mango juice alone.

Mango Juice: given orally

Arm 2

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Due to the study's early termination and low accrual, data were not collected for all study objectives assessment.

Senior Administrator, Compliance - Clinical Research Services

Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0

Due to the study's early termination and low accrual, data were not collected for this assessment.

Apoptosis, Cell Proliferation, and Microvessel Density

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Hyperplasia

Breast Diseases

Skin Diseases

Antineoplastic Agents

Other Dietary Supplements

Sulforaphane

Patients will be randomized to 14 day intervention of broccoli sprout extract and mango juice consisting of a dose of 100 µmols of sulforaphane dissolved in 150 mL mango juice once a day.

Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.

Broccoli sprout extract

Mango juice

Kala Visvanathan, MD

The purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. In addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.

A double-blind randomized Phase II chemoprevention trial of BSE versus placebo will be conducted in up to 35 women diagnosed with DCIS on core biopsy prior to their definitive surgery (study diagram below). The primary study endpoint will be a decrease in the mean proliferative rate measured by Ki67%.

Women diagnosed with DCIS on core or incisional/excisional biopsy scheduled for definitive surgery at Johns Hopkins Hospital will be recruited for this study. Participants will be placed on a cruciferous free diet for the 14 days prior to their surgical date and drink a randomized intervention beverage (mango juice with or without broccoli sprout extract). Additionally participants will provide 2 blood and 2 urine sample collections, report medication use and adverse events using prepared forms and complete a daily diet check list during the 14 day intervention. On the day of definitive breast surgery, 1-2 grams of breast tissue (including normal adjacent breast tissue) will be collected during surgery.

Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue

Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk

Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.

Phase II protein expression of cytoprotective enzymes known to be modulated by sulforaphane in DCIS specimens.

Cytoprotective enzymes measured (NQ01 and AKR1C1 expression) based on immunohistochemical analysis. Expression was categorized by the study pathologist based on percentage of cells expressing antibody on the slide.

Breast Cancer Research Foundation

Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice compared to a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).

Broccoli sprout extract (sulforaphane): Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to either a prepartion of broccoli sprout extract and mango juice or a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study.

Broccoli Sprout Extract and Mango Juice

Patients will be randomized to 14 day intervention of Mango juice without broccoli extract. All women will be on a cruciferous free diet for the duration of the study (14 days).

Mango juice: Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to either a prepartion of broccoli sprout extract and mango juice or a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study.

Age collected on baseline survey. Participants had to be 18+ years old

United States

Region of Enrollment

Eligible patients had to have their definitive breast cancer surgery at Johns Hopkins Hospital

Dr. Kala Visvanathan

Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).

Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).

Mango Juice Without Extract

All participants who completed the 14-day intervention on either study arm were included in analysis.

Absolute Change in Mean Proliferative Rate Measured by Ki67%

AKR1C1

NQO1

Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor

Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice compared to a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).

Broccoli sprout extract (sulforaphane): Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to receive a prepartion of broccoli sprout extract and mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study.

Patients will be randomized to 14 day intervention of mango juice without broccoli sprout extract. All women will be on a cruciferous free diet for the duration of the study (14 days).Mango juice without extract: Mango juice without broccoli sprout extract.

B Mango juice: Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to receive a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study.

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Carcinoma, Ductal

Adenocarcinoma

Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.

Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

Broccoli Sprout Extract

Laboratory Biomarker Analysis

Pharmacological Study

Placebo

Jessica Young

This randomized pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.

PRIMARY OBJECTIVES:

I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.

II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).

III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.

IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.

SECONDARY OBJECTIVES:

I. To determine tolerability of ITC-BSE and compliance in breast cancer patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.

ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

After completion of study treatment, patients are followed up at 30 days.

Broccoli Sprout Extract in Treating Patients With Breast Cancer

A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer

Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Broccoli Sprout Extract in Preventing Lung Cancer in Smokers	NCT00255775	Lung Cancer	broccoli sprout... complementary o...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery	NCT01108003	Recurrent Bladd... Stage 0 Bladder... Stage I Bladder... Stage II Bladde... Transitional Ce...	broccoli sprout... laboratory biom... Mango Juice	18 Years -	Roswell Park Cancer Institute
Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue	NCT00982319	Breast Cancer	Broccoli sprout... Mango juice	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Broccoli Sprout Extract in Treating Patients With Breast Cancer	NCT01753908	Ductal Breast C... Ductal Breast C... Estrogen Recept... Estrogen Recept... Invasive Breast... Lobular Breast ... Postmenopausal Stage IA Breast... Stage IB Breast... Stage IIA Breas... Stage IIB Breas...	Broccoli Sprout... Laboratory Biom... Pharmacological... Placebo	21 Years -	Roswell Park Cancer Institute
Broccoli Sprout Extract in Preventing Lung Cancer in Smokers	NCT00255775	Lung Cancer	broccoli sprout... complementary o...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery	NCT01108003	Recurrent Bladd... Stage 0 Bladder... Stage I Bladder... Stage II Bladde... Transitional Ce...	broccoli sprout... laboratory biom... Mango Juice	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for broccoli sprout extract