A Phase 2 interventional study of Broccoli sprout extract and Mango juice in Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Prevention
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.
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This study's enrollment of 34 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
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Exclusion Criteria:
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.
Drug: Broccoli sprout extract · Drug: Mango juice
Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.
Drug: Mango juice
100 µmols of sulforaphane (dissolvable)
150 mL of mango juice
Absolute Change in Mean Proliferative Rate Measured by Ki67%
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.
Time frame: Change from baseline to 14 days post-intervention
Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor
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.
Time frame: Change from baseline to 14 days post-intervention
| Milestone | Broccoli Sprout Extract and Mango Juice | Mango Juice |
|---|---|---|
| Started | 17 | 17 |
| Completed | 15 | 15 |
| Not completed | 2 | 2 |
| Withdrew: Surgery date change | 1 | 0 |
| Withdrew: Preop values out of acceptable range | 1 | 1 |
| Withdrew: Pregnancy | 0 | 1 |
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.
| percentage of Ki67 | Broccoli Sprout Extract and Mango Juice | Mango Juice Without Extract |
|---|---|---|
| Absolute Change in Mean Proliferative Rate Measured by Ki67% | -1.15 ± 2.08 | 4 ± 17.08 |
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.
| % change of expression in tumor cells | Broccoli Sprout Extract and Mango Juice | Mango Juice Without Extract |
|---|---|---|
| AKR1C1 | 62.1 ± 312.99 | 867.4 ± 2097.8 |
| NQO1 | 730.98 ± 2411.96 | 6.34 ± 30.12 |
Collected over 14 days during the intervention period (prior to first and 3 times during intervention). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Broccoli Sprout Extract and Mango Juice | 0/15 (0%) | 0/15 (0%) | 9/15 (60%) |
| Mango Juice | 0/15 (0%) | 0/15 (0%) | 9/15 (60%) |
| Event | Broccoli Sprout Extract and Mango Juice | Mango Juice |
|---|---|---|
| constipationGastrointestinal disorders | 5/15 | 4/15 |
| intestional gas/bloatingGastrointestinal disorders | 4/15 | 2/15 |
| abdominal crampsGastrointestinal disorders | 0/15 | 2/15 |
| appetite/ taste alterationGastrointestinal disorders | 2/15 | 1/15 |
| upset stomach/indigestionGastrointestinal disorders | 1/15 | 1/15 |
| nausea/vomitingGastrointestinal disorders | 1/15 | 0/15 |
| diarrheaGastrointestinal disorders | 1/15 | 0/15 |
| light headed/ mild anxietyNervous system disorders | 1/15 | 1/15 |
| Age, Categorical(Participants) | Broccoli Sprout Extract and Mango Juice | Mango Juice | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 25 |
| >=65 years | 2 | 3 | 5 |
| Age, Continuous(years) | Broccoli Sprout Extract and Mango Juice | Mango Juice | Total |
|---|---|---|---|
| Median | 52 (35 to 71) | 54 (40 to 72) | 53 (35 to 72) |
| Sex: Female, Male(Participants) | Broccoli Sprout Extract and Mango Juice | Mango Juice | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Broccoli Sprout Extract and Mango Juice | Mango Juice | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins